FDA Recalls in 2022

DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

Synthes GMBH is reporting Recall of SYNMESH CAGE SYSTEM Japan-Specific Country Label Issue . The Japan affiliate will be administering the recall per their local regulations, the week of September 21, 2020. Affiliate will notify Japanese sales representatives. Japanese sales representatives will hand-deliver notices to affected hospitals / surgeons. The Japan affiliate is responsible for managing the rework process. Returned devices will be reworked with correct Japan-specific labels and revised lots

Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.

On 03/25/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via postal mail or email to customers informing them that Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results. In a worst-case scenario, unvalidated or incorrectly validated rules may lead to the generation of erroneous test results that may be reported out of the laboratory. For customers using versions 1.5, 1.6, 1.7, 1.8 or 1.9 are instructed: 1. Validate the rules that were unvalidated or incorrectly validated, according to laboratory procedures 2. All rules set up in the future must be validated, according to laboratory procedures The Recalling Firm strongly encourages the use of the testing instructions provided with this notification, "REMISOL Avanced v1.5 through v1.9 Rule Validation Procedure". The Recalling Firm is currently updating the Instructions For Use for the affected versions and is targeting May 2021 for availability. Customer are also instructed to: -Share this information with their laboratory staff and to retain this information as part of their laboratory Quality System documentation. -If customers are a centralized license holder, they are asked to provide the other affected laboratories of their organization or association with a copy of the notification letter. -Within 10 days of receiving this customer notification, customers are asked to communicate with the Recalling Firm either: 1) Electronically, if they received this communication via email, or 2) Manually, complete and return the enclosed Response Form. For further questions, contact the Recalling Firm via -Website http://www.beckmancoulter.com or -By phone - contact their local Beckman Coulter representative.

Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.

Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.

Getinge sent a customer letter dated July 2020 instructing customers to remove the affected products from areas of use and return the product(s) to Getinge following the provided instructions.

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.

The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

On 04/01/2021, LeMaitre issued an Urgent Medical Device Removal notice via letter informing customers that particulate contamination has been detected from the packaging foam with these devices.

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603

SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans

Siemens issued notification Urgent Medical Device Correction letter on 7/25/19 issued via electronic mail to consignees or by USPS certified mail if a consignee email address was not available. Letter states problem, health risk, action to take: The remote software update installation process will require approximately 30 minutes for completion. The process is completely automatic; make sure the system and power are stable before and during the process and do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled. If your system is connected to Siemens Remote Connection, this update will be performed remotely. Following the corrective action, the cause will be eliminated and a recurrence of the identified issues is prevented. If you have any questions, please contact our service organization at 1-800-888-7436.

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.

Presence of foreign substance

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Failed Impurities/Degradation Specifications

Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

22 oz Blonde; 20 oz Blonde EZ; 24 oz Blonde EZ frozen pizza dough manufactured by It'll Be Pizza

Product may be contaminated with foreign object (debris from packaging).

Red Button Vintage Creamery French Silk Pie, Net Wt. 31.88 oz. (904g), in a clear plastic dome and black plastic base, UPC 0 41172 81290 9, Distributed By: Associated Food Stores, Salt Lake City, Utah 84119 RMYA0421" printed on sleeve. Keep refrigerated.

Pies labeled as Red Button French Silk may contain Turtle Cream Pies containing almonds which are not declared on the French Silk label.

EGA 22 oz Pizza Dough Ball, 20 ct/ case; frozen pizza dough

Product may be contaminated with foreign object (debris from packaging).

Gamesa Arcoiris Marshmallow Cookies, Naturally and Artificially Flavored 15.5 Oz, 6 Count UPC 6 86700 10132 4

Potential to contain Salmonella

Take 2 Classic 18 oz, 24 ct/case; Take 2 Classic 20 oz, 22 ct/case; Take 2 Specialty Traditional 20oz, 22ct/case frozen pizza dough manufactured by It'll Be Pizza

Product may be contaminated with foreign object (debris from packaging).

24 oz Beer, frozen pizza dough manufactured by It'll Be Pizza

Product may be contaminated with foreign object (debris from packaging).

Brava, 20 oz, 22 ct/case and Brava, 24 oz, 18 ct/case frozen pizza dough

Product may be contaminated with foreign object (debris from packaging).

King Oscar Anchovies Flat Fillet in Olive Oil 2 oz. can 18 cans per carton UPC number: 3480060061 Ingredients: Anchovies, Olive Oil, Salt. Packed in Peru Distributed by: Tri-Union Seafoods, LLC, El Segundo, CA 90245 USA

Anchovies found to have elevated levels of histamine

Circle K 22 oz Blonde Pizza Dough balls, 20 ct/case; frozen pizza dough

Product may be contaminated with foreign object (debris from packaging).

20 oz Garlic and 24 oz Garlic frozen pizza dough manufactured by It'll Be Pizza

Product may be contaminated with foreign object (debris from packaging).

Utopia brand Enoki Mushroom; Utopia Foods Inc; 200g; Product of China; Distributed by Utopia Foods Inc.; UPC 892891861017; packaged in blue and clear plastic bag

Product may be contaminated with Listeria monocytogenes.

Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

The recall strategy outlined below addresses the depth of the recall and recall notification (customer letter) effectiveness check. This issue will be resolved by sending an Urgent Medical Device Correction letter (attached) to customers with potentially affected systems. This letter will inform the customer of the issue and provide safety instructions for continued use. GE Healthcare will inspect potentially affected systems and correct, if needed. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the inspection and correction, if needed, of potentially affected systems. Records will be retained per our processes and procedures.

KERRY PRE IDQ 61-03 TND 50# 227262 300-121584, NET WEIGHT: 50 LB (22.68KG) INGREDIENTS: Bleached Enriched Wheat Flour***Bread Crumbs***Corn Syrup Solids, Dried Yeast, Soybean Oil, Salt, Mono and Diglycerides, Malted Barley Flour, Ammonium Sulfate, Leavening***Less Than 2% Silicon Dioxide (Anti-Caking), CONTAINS: WHEAT UPC 0 50576 24323 3 Kerry Inc. 3330 MIllington Road, Beloit, WI 53511

The firm is recalling their flour based breading due to the presence of egg allergen which is not listed on the label.

Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.

Urgent: Medical Device Recall notification letters dated 11/18/19 were sent to customers. Please discontinue use. Attached is a Reply Communication form that should be used to let us know whether the product has been used or will be returned. Once we receive that Form, a Customer Service agent will reach out to you with return instructions and provide a label if necessary. Paltop Advanced Dental will replace the implants that are in stock.

VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays.

A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.

On 01/18/2021, Ortho Clinical Diagnostics issued an Urgent Product Correction Notification via e-mail due to a a deformity in a specific lot of VITROS Chemistry Products VersaTips. The affected product is to be no longer distributed and discarded.

JUDKINS PACK

Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource kit SANHDJTVCF Judkins Pack lot # 525067.

The notice "Presource Kits Containing an Incorrect Medication Label Sheet" and reply form dated 02/11/2021 were sent to the customer. For questions, requiring additional labels, or desire special assistance relating to this notice, contact Cardinal Health Quality Systems at 800.292.9332.

ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.

cGMP Deviations

FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01

Underfilled units.

Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26

Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

cGMP Deviations

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.

cGMP Deviations

Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

cGMP Deviations

PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.

Note: This recall is specific to this single lot of PROCEED Surgical Mesh. Health care practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required. Product subject to the recall in your inventory can be identified by the product code information described in the above table. all unused PROCEED Surgical Mesh subject to this recall are required to be returned. Please utilize attachment 1 for assistance in identifying the product lots subject to this recall. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (Attachment 2) confirming receipt of this notice and return to Ethicon sales representative or distributor by [INSERT DATE]. Please return the Business Reply Form even if you do not have products subject to this recall. 5. Follow instructions in the letter and immediately return unused impacted PROCEED Surgical Mesh subject to this recall to Ethicon sales representative or distributor. To receive credit reimbursement, customers must return product subject to this recall. Any non-affected product and any product returned after the date specified will not receive credit. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon Korea. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your re

iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157

iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.

An urgent medical device recall letter, dated 11/10/2017, was sent to customers informing them that Beckman Coulter was initiating a field action for the iQ200 Series Urine Microscopy Analyzer with Barcode Reader, which may fail to read urine sample dilution barcode labels instead defaulting to no dilution, dilution factor of 1:1. In addition, this product may also fail to read urine sample dilution barcode labels, when the rack is rejected, leading to no results. Customers were informed of the issue, impact, action, and that the resolution was being investigated. Customers were instructed to respond within 10 days: electronically via email or manually by completing and returning the response form accompanying the device recall letter. Customers with questions regarding the notice were instructed to contact the Customer Support Center: electronically at http://www.beckmancoulter.com/customersupport/support or via phone at 1-800-854-3633, in the United States and Canada. Customers with questions located outside the United States and Canada, were instructed to contact local Beckman Coulter representatives.

Sardines in tomato sauce packed in cans labeled in part, "WILD PACIFIC SARDINES RAINCOAST TRADING TM***IN TOMATO SAUCE***NET. 4.2 oz (120 g)***INGREDIENTS: SARDINES, WATER, TOMATO PASTE, SEA SALT. PRODUCT OF MALAYSIA PACKED FOR: RAINCOAST TRADING, NANAIMO, BC CANADA V9R6Z5***8 10757 00917 7***BEST BEFORE 19 JUL 2024***"

Canned sardines in tomato sauce recalled due to high levels of histamine.

(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-

Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.

All affected customers were sent a letter on 09/03/2020 stating the following : Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization. Zimmer Biomet will follow up w/ consignees that have not responded after the initial notification. Additional notifications via telephone, fax, email, or traceable carrier will be sent to those who have not completed the required certification form or provided surgeon and hospital information/confirmation. 100% of the delivery notifications will be accounted for. An inventory return certification form will be returned from each distributor that certifies that all available products from their territory have been returned or accounted for. Affected products that are not returned or accounted for will be considered as "not in inventory and unavailable for return." Zimmer Biomet will deem accounts unresponsive after 3 effectiveness checks if there continues to be no response are making reasonable efforts. Product that has not been recovered rom unresponsive consignees will be reported as unaccounted for. Product returned from the field will be scrapped.

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

The firm initiated the recall by letter on 12/15/2020. The letter requested the following: "INSTRUCTIONS TO CUSTOMERS AND DISTRIBUTORS: 1. Locate affected product in your possession by referring to the Affected Devices List (Table 1) listed on this Recall Notice. 2. Determine the number of affected devices in your possession and complete the Response Form (Attachment 1) within 10 days of receipt, returning it to fieldactions@smiths-medical.com. The form must be returned even if you do not have any affected Bivona Cuffless FlexTend Tracheostomy Tube Devices in your possession. 3. All affected product must be returned to Smiths Medical for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. When returning product please include a copy of the Response Form (Attachment 1) inside EACH BOX. 4. Product credit will be processed once the impacted product and Response Form (Attachment 1) has been received and processed. 5. DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall with the editable Response Form for your customers (Attachment 1a) to respond appropriately."

Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times.

Smiths Medical became aware that three lot numbers of a specific model of Bivona Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.

Distribution of the "URGENT MEDICAL DEVICE RECALL NOTICE" dated 01/29/2021 during the week of January 18, 2021.

DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.

Inability for the user to inject the paste from the syringe into the target location.

On 04/01/2021, Stryker issued an Urgent Medical Device Removal notice via letter informing customers that users have reported the inability to push the paste through the Mixer-Cannula which prohibits the injection into a bone void.

Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.

A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.

On 11/9/2020, Canon issued a "Urgent: Medical Device Correction" letter to all affected customers via facsimile. In addition, to informing consignees about the recall, the firm ask affected consignees to take the following actions: 1. Until corrective action has been taken, in order to avoid the problem, please use the system with setting InstaView OFF according to the last notification (dated June 2020) Subject: Abnormality in Realtime Reconstruction Images. Please see Attachment A. 2. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. 3. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon service representative at (800) 521-1968.

Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.

Tungsten coils of the guidewire included in the introducer kit were detaching.

On 04/26/2020, the recalling firm sent Urgent Medical Device Recall letter by email to the affected customer/hospital/distributor. The letter will identify the product, the problem, and the action to be taken by the recipient (customer).

FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

On 07/20/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customer informing them that an issue has been identified in the manufacturing process which might contribute to elevated rates of false negative results while using the BCID Panel. Actions to be taken by customers: 1) Immediately examine their inventory for product identified in this recall, 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Complete the accompanying Field Action Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to the Recalling Firm so that it may acknowledge their receipt of this notification. 4) If they may have further distributed the affected product, identify any recipients and notify them at once of this product recall. For product replacement, as well as any other questions or concerns, contact customer support department at Support@biofiredx.com or via telephone at 1-800-735-6544 and selecting option 5 for Product Technical Support.

Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose informat

It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.

On the date of August 16, 2019, Dexcom provided their consignees with an "Urgent Customer Notification - Please Read" letter concerning the recall via UPS. In addition to informing the consignees about the recall, the letter asked customers to take the following action: 1. Determine if your receiver is impacted: - The following Receiver Part Numbers are impacted (the receiver part number is located on the back of your receiver): Part Number: MT22719, Part Description: Dexcom G5 Mobile receiver (Black, Pink and Blue) 2. Determine if your software version is impacted: - Power on your Receiver - Navigate to the Main Menu - Press the Down Arrow and select Settings - Press the Down Arrow and select Device Info - The Part Number, Software Number and Software Revision are shown 3. If your Dexcom G5 Mobile Receiver software version is not 4.0.1.048, no further action is required. 4. Update Receiver Software using the Update Tool if Software Number is SW10617 and Software Revision is 4.0.1.048: - Go to: https://store.dexcom.com/user/login and sign in to your Dexcom Account. If you do not have an account, you can create one from this page. - Click on Update on the Update Tool icon: - You will be taken through a series of steps to update, which will take less than 15 minutes. - When the Update Tool download progress displays 'Update Verified ... all done', your Receiver will reboot and the Time/Date settings screen will display. At this point, the software download is complete. Confirm the date and time, and you can use your updated receiver. - For questions, please reference the Update Tool FAQs: https://www.dexcom.com/faq/how-do-i-install-update-tool 5. If your Dexcom G5 Mobile Receiver is not available, you can alternatively use the Dexcom G5 Mobile App to receive your glucose readings and alerts. This can be installed on your compatible smartphone by visiting the Apple Store or Google Play Store. For compatible devices and operating system

Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing Transparent 4 X 4 1 Glove Perry 6.5 PF Steril 1 Bowl Fluid Containment W/Li 1 Cover backtable 50 X 90 Zon 1 Cup medicine 2 oz clear 2 Stopcock 3 way rot m/l/l 2 Needle RB 22x 1.5 1 Spike B

Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

On March 26, 2021, Windstone Medical Packaging dba Aligned Medical Solutions issued a "Urgent Medical Device Recall notification to affected consignees via US Mail. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Due to the manufacturing process and finished sterilized packs, if any, in inventory, or at your facility, over labeling of inventory affected by this recall will be labeled with a sticker attached to each pack. The sticker will read: "Recall Notice Smith Medical announced the recall of the angio tubing contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall, 1. At the time the kit is opened for use any angio tubing manufactured by Smith Medical should be identified and set aside, 2 The recalled tubing should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. 2. Please complete the attached AMS recall reply form and return it to Aligned Medical Solutions at the Fax number provided on the form. If you do not have the affected product you must complete and return the AMS Recall Reply Form. replacement product will be issued upon request and completion of the attached Recall Reply For. 3 If you have any questions or concerns, please contact Vicki Davis, Quality Manager, 407-638-9924

BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

On 5/10/21, BioFire distributed a "Urgent: Medical Device Correction" letter to all consignees via: E-Mail. In addition to providing consignees with a recall notification, the firm ask consignees to take the following actions: 1 Immediately examine your inventory for product identified in this recall (BCI 2 Panel Pouch Lot # 11YA20/ Kit Lot # 2039020). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. BioFire will replace the product at no charge in accordance with Biofire's Standard limited Warranty 3.Confirm the amount of pouches scrapped (if any) on the attached acknowledgement of receipt form. 4. If you may have further distributed this product, please identify any recipients and notify them at once of this product recall. 5. Please complete the accompanying Field Action acknowledgement of receipt Form and return to BioFire so that BioFire may acknowledge your receipt of this notification. 6. If you have any questions or concerns, please contact our customer support department at support@biofiredx.com or via phone at 1.800.735.6544. 7. Adverse events may also be reported to FDA's MedWatch Adverse Event Reporting program.

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

On 4/22/2020 the firm issued an "URGENT Medical Device Correction" letter via UPS/certified mail, informing them that as a result of 3 complaints in 2019 in which a catheter became entrapped in the cardiac valvular apparatus while the user was attempting to create an electroanatomic map, leading to the need for surgical intervention for removal, the firm is performing a correction to the products. The Notification Letter informs customers: Following are learnings that users of this product should be aware of to avoid or address entrapment: " Repeated rotation of the catheter near the valvular apparatus may result in the entanglement of the product spines and further rotation could result in entrapment, leading to the need for surgical intervention. " A common use scenario for repeated rotation leading to entanglement may occur during mapping of the right ventricle and accessing of the right ventricular outflow tract using clockwise rotation. Caution should be exercised with manipulation to avoid spine entanglement with valvular structures. " Entanglement of the catheter can be identified by resistance felt by the user and a lack of movement of the spines during manipulation, which can be seen via the CARTO 3 System or by fluoroscopy. The device may appear in a broom-like configuration with entangled spines pointing in a single direction. With opposite manipulation (e.g. counterclockwise rotation for initial clockwise rotation), it may be possible to free the entangled device for safe removal. " Do not use excessive force to remove the device when entangled or entrapped as it may lead to damage to the cardiac structures or to the device. The firm is instructing customers: 1. Please maintain awareness of this letter and pass it on to anyone in your facility that needs to be informed. 2. Please complete, sign, and return the Business Reply Form. We have communicated this information to the applicable regulatory authorities. Method of Notification/M

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

Lack of sterility assurance: Bags have the potential to leak.