FDA Recalls in 2020

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.

CGMP Deviations

Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002

Lack of CGMPs:

Chef Myron's Szechuan Sauce, 64 FL OZ (1.89 L), Item # 400023293, 4 bottles/case

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

Good & Gather Banana Chocolate Chip Date & Nut Bars, UPC 0 85239-04216 8. 5-1.6 oz (45g) Bars. Net Wt. 8oz (225g). DIST BY: Target Corporation, Minneapolis, MN 55403.

The product contains an undeclared almonds.

Tomato Paste in a 6 oz.(170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Happy Harvest, Kroger, Signature Select, Food Club, Members Mark, Great Value, Essential Everyday, Summer is Inside, Harmons, Pastene, Avenue A.

Presence of metal shavings in tomato paste

Italian Style Tomato Paste in a 6 oz. (170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Kroger, Signature Select, Harris Teeter, Food Club, Essential Everyday, Raleys, Fareway.

Presence of metal shavings in tomato paste

Prairie Farms Premium Flavored Chocolate Milk, 1 gallon, UPC 72730-26110

The product contains undeclared egg.

On the Go Sweet & Salty Trail Mix

Almonds were found inside packages which do not state they contain almonds.

Prairie Farms 1% Lowfat Chocolate Milk, 1 gallon, UPC 72730-26126

The product contains undeclared egg.

Victoria Taylor Seasonings Sicilian Seasoning/Assaisonement Sicilien; Italian style seasoning blend; 2.5oz; packaged in a glass jar. Canadian product only.

Product contains undeclared sesame.

Golden Boy brand Custard muffin Pandan 7.76 ounce, rigid clear plastic packages

Product contain undeclared milk.

Golden Boy brand Custard muffin Original; 7.76 ounce, rigid clear plastic packages

Products contain undeclared milk and Uranine-Acid Yellow 73

Chef Myron's Tangy Teriyaki Sauce, 64 FL OZ (1.89 L), Item # 400023221, 4 bottles/case

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

Whole Foods Market Popcorn Chicken Shaker with Sweet Chili Variable weight sold by lb. Packed For Whole Foods Market

Undeclared allergen (shrimp) due to product mislabeling.

Chef Myron's Premium Teriyaki Sauce, 64 FL OZ (1.89 L), Item # 400023118, 4 bottles/case

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

Hy-Vee, Short Cuts, Pot Roast Mix sold by weight in approximate 1 lb containers, Distributed by Hy-Vee Inc, West Des Moines, IA UPC 272083 XXXXXX

An ingredient used as an ingredient in the products tested positive for Listeria monocytogenes

HomeChef meal kit: Buffalo Pretzel Chicken Breast with Roasted Cauliflower and Broccoli. 29 ounce.

Supplier provided ingredient (pretzel breading) was SUSPECT for Listeria species, but no further confirmation was performed to confirm the suspect result. Lot number of ingredient in question: 0924032501

HomeChef Meal kit:One-Sheet Pretzel-Crusted Chicken with roasted broccoli and honey mustard..31.0 OZ (1 LB 15 OZ) 879g

Chef Myron's Yakitori Sauce, 64 FL OZ (1.89 L), Item # 400023316, 4 bottles/case

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

Chef Myron's Premium Shoyu Sauce, 1 GAL (3.78 L), Item # 400023077, 2 bottles/case; 5 GAL (18.92 L), Item # 400023279, plastic pail

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

SAROS Oxygen System Model 3000

There is an electronics control issue that causes the unit to not power on with battery power only.

The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units.

CardioLab/ComboLab Recording Systems

Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.

GE Healthcare notified customers of the recall on about 09/16/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that certain CLab II Plus Amplifiers used with CardioLab/ComboLab systems have failed the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient. Instructions included that customers could continue to use the system by following the below instructions: 1. Test all equipment used in conjunction with CardioLab/ComboLab per manufacturer instructions on electrical safety to ensure that all equipment is in good operating condition and performs per manufacturer specifications. Note: Due to the potential safety risks of other devices used in conjunction with CLab II Plus Amplifiers in Electrophysiology Procedures, all equipment that can electrically contact the patient during a procedure should be checked against each devices safety conformances in manufacturer specifications. 2. If you suspect another connected device is or may be malfunctioning, discontinue use of the CLab II Plus Amplifier until all nonconforming equipment is corrected. If nonconforming equipment is used in conjunction with the CLab II Plus Amplifier, the CLab II Plus Amplifier will not provide necessary mitigation to prevent patient shock. Customers were also informed that GE Healthcare will correct all affected products and a GE Healthcare representative will contact customers to arrange for the correction. They were asked to complete and return the "MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT" form.

DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician

Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.

The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" dated 12/17/2018 to its consignees by letter on 12/17/2018. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: 1) Check your inventory for the specific product and lot number listed. 2) If you have affected inventory, complete the Notice of Return Form and return it to recalls@deroyal.com or fax to: 865-362-3716 not later than January 29, 2019. 3) PLEASE COMPLETE THIS FORM AND RETURN IT EVEN IF YOU NO LONGER HAVE ANY INVENTORY.PL EASE CONTACT CUSTOMER SERVICE REPRESENTATIVE AT 865-362-4203 OR EMAIL AT JMARSH@DEROYAL.COM FOR RETURN INFORMATION. 4) Once we have received your Notice of Return Form, you will be given credit or replacements as you have indicated on the form. 5) If you have further distributed these products, it is required that your customers be notified of this recall. You may either do this directly and notify us that you have done so, or you may provide us with your customer listing and we will contact them. If you have questions or need assistance with the recall, please contact your DeRoyal Representative, customer service at 888.938.7828, or email us at recalls@deroyal.com.

Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

The firm initiated the recall by letter on 04/25/2018. The letter identified the affected product, problem and actions to be taken. the firm requested the return of the product. Distributors were directed to conduct a sub-recall, requesting their customers return the product to the entity from whom they received the product.

GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems.

Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

On May 17, 2019, GE Healthcare sent letters to all of their consignees advising them of the recall, providing them with new instructions for use, and requesting that they complete the enclosed MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED forms. GE will follow-up and correct these systems,

SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.

On May 2, 2019, the firm sent Guidance for SenTec Distributors to their distributors advising them of the issue, requesting them to check their stock and notify their end users via a voluntarily initiated field correction action associated with Membrane Changers and their Inserts which was enclosed with the "recall" letters. The distributors were to report back to SenTec via email.

Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.

On April 25, 2019, the firm sent Additional Items - Lots Affected URGENT RECALL MEDLINE INDUSTRIES IMMEDIATE ACTION REQUIRED letters to 61 consignees advising them of the problem, requesting that they apply stickers to any subject item/lot, and return the Verification Form. On May 15, 2019, the firm sent out a second recall letter to 36 consignees.

SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20

Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

On June 3, 2019, SunTech Medical sent an Urgent Medical Device Customer Notification to their one consignees advising them of the issue and requesting that they completed the enclosed Recall Acknowledgement Form. This letter further request this consignee to conduct a sub-recall by using the provided Customer Template Letter and Recall Acknowledgement Template.

GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems

On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.

The firm issued a medical device correction notice on 07/24/2018. The notice explained the issue and provided safety instructions should the use observe a switch change. The units will be corrected. Questions or concerns may contact 1-800-437-1171 or the local service representative.

VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.

Customers have reported that some VITEK 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.

Consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on 07/12/2017. The direct consignees (subsidiaries and distributors) have until 08/12/2017 to notify their respective impacted users. The directions to the user are as follows: Please implement the following actions at this time: " Confirm this letter has been distributed to, and reviewed by, all appropriate personnel within your organization. " Refrain from performing the VITEK 2 Systems Software 8.01 update. o A solution has been identified, and your local bioMrieux representative will contact you with further instruction in the coming weeks. " If you have updated VITEK 2 Systems Software to version 8.01 within the last seven (7) days, please contact your local bioMrieux representative. " Please store this letter with your bioMrieux instrument documentation. " Complete the Acknowledgement Form and return it to your local bioMrieux representative."

Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems

the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System

The firm, Accuray, disseminated their "Urgent Field Safety Notices" dated 08/31/2018 by email and letter to its customers. The letter described the product, problem and actions to be taken. The letter requested the customers cease use and quarantine the product for recovery and replacement by an Accuray Representative and complete and return the Acknowledgement Form via email at: astsauver@accuray.com or mail to: Accuray Incorporated, one Erdman place, Madison, WI 53719. If you have any questions, contact Vice President, Regulatory Affairs at 608-824-2800 or email: dbiank@accuray.com or the Regulatory Affairs Specialist at 408-716-4660 or jysingh@accuray.com.

Chef Myron's Ponzu Sauce, 64 FL OZ (1.89 L), Item # 400023110, 4 bottles/case

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

Chef Myron's Eurasian Fusion Sauce, 64 FL OZ (1.89 L), Item # 400023288, 4 bottles/case.

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

1. Fresh Attitude Baby Spinach, 11 oz. 2. Fresh Attitude Baby Spinach, 5 oz.

Spinach may be contaminated with Salmonella

HomeChef meal kit:Steak and Walnut-Green Onion Sauce with roasted potatoes and creamed spinach.

Hy-Vee, Short Cuts, Grill Ready Veggie Mix sold by weight in approximate 1 lb containers, Distributed by Hy-Vee Inc, West Des Moines, IA UPC 272104 XXXXXX

An ingredient used as an ingredient in the products tested positive for Listeria monocytogenes

Chef Myron's Tsukeyaki Sauce, 64 FL OZ (1.89 L), Item # 400023276, 4 bottles/case

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

PENTARAY NAV High-Density Mapping Catheter.

Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

Recall Notification letter, dated 04/14/2016, and Acknowledgement Form was sent to customers via express mail on 05/17/2017. Instructions included to read and follow Labeling Correction Notice carefully, provide the notice to anyone in the facility that should be aware, sign and return the Acknowledgement Form, and to maintain awareness of the correction.

IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.

Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.

An Urgent Field Safety Notice was sent to accounts via email on 9/1/2015. The letter described the safety alert. Customers were informed of the problem and that Service would be contacting them to arrange a date to deploy the corrective action and install the Service Update at their facility. An acknowledgement was included which was to be faxed back or emailed back to Agfa.

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

Intersurgical Inc. issued Urgent Medical Device Recall notices to customers dated August 5, 2019. Customers were advised to take the following actions: 1. Immediately discontinue use and quarantine any stock with the product/lot number described in the recall notification. 2. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number. Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST. a. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form: i. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com. ii. The subject line should contain your Company name and RGA number. 1. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return. b. Intersurgical will credit your account when the product is received. 4. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form. a. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com. b. The subject line should contain your Company name and Intersurgical Recall

Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.

The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.

The firm, Ohio Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 8/7/2018 to its customers on 8/14/2018. The letter described the product, problem and actions to be taken. The customers were instructed to take the affected care-e-vac3 units out of service and follow the instructions, site: https://www.ohiomedical.com/4897450, provided with this notification to change the orientation of the battery; If, upon opening the device, you identify damage to wiring, please contact Ohio Medical Customer Service at 866.549.6446 or email to customer.service@ohiomedical.com for additional instructions to replace the wiring harness; and complete the attached Customer Acknowledgement Form and return it to our Quality Assurance Department at 847/855-6304 (fax), email to: CEV3_FCA@ohiomedical.com, or mail in the envelope provided to: Ohio Medical LLC, ATTN: Quality Assurance Department, 1111 Lakeside Drive, Gurnee, IL 60031. Please direct questions to Sr. Director, QA/RA at 847-855-6326 or email: barbara-ann.conway-myers@ohiomedical.com.

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Incorrect product and/or label. Sizing is labeled incorrectly.

An URGENT MEDICAL DEVICE RECALL was sent on December 05, 2017 Product Field Action #: 1658081 Description: MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7 Item No.: 180612; Lot Number: 26080317-01180617; and Lot Number: 26150217-01 Dear Customer, Stryker has initiated an urgent, voluntary, lot-specific recall for the MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLA TE-RM/LL-SZ 7 referenced above. The intent of this letter is to inform you of the product recall that was initiated on December 01, 2017 by Stryker, and to list known hazards potentially associated with the use of the above referenced products and list the risk mitigation factors. Stryker has discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. Two reports were received with the product/label discrepancy. In one report, the labeling of the implant box outer label stated Size 2 RM/LL, and the labeling of the implant sticker (Patient label) located inside the outer box stated Size 7 RM/LL. The correct implant Size 2RM/LL was inside the box. The patient label was incorrect in this report. The second report described that a size 2 implant was in a box labeled as a size 7 implant. Potential Hazards Technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. Additional communication will be forwarded upon completion of the internal investigation on this issue. Risk Mitigation The difference in Size 2 RM/LL implant and Size 7 RM/LL implant is easily identified by the end user and would not likely be implanted as the discrepancy would be obvious. Actions Needed 1. Please inform users of this Urgent Product Recall and forward this notice to all individuals who need to be aware within your organization 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Recall Notification Business Reply Form and

BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculatin

Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.

The firm notified their consignees by email on November 3, 2017. "Instructions to customers what to do with the recalled product. For instructions for the user how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue, please also refer to the User Corrective Action section in the attached Field Safety Notice / Product Notification letter CAPA-20171011-001985: 1. After applying a couch shift always perform a verification image of the patient position before enabling the treatment beam. 2. Do not use the Virtual Isocenter function if a verification of the patient position in the treatment isocenter is not feasible. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning in the Clinical User Guide ExacTrac Vero: Brainlab highly recommends performing an X-ray verification after each change to the couch/Robotics Position." For further questions, please call 1 (800) 784-7700.

Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.

Product was manufactured utilizing an expired inner body.

Cordis notified customers on about 10/04/2019, via Urgent MEDICAL DEVICE RECALL letter delivered by sales representatives. Customers were informed that the Cordis MAXI LD" PTA Dilatation Catheter was manufactured utilizing an expired inner body. For an expired inner body, a degradation of material may contribute to a collapse of the guidewire lumen resulting in a resistance during insertion or backloading of the guidewire into the lumen. Instructions included to read the recall letter, immediately check inventory to conform if the affected product is in your possession, identify and set aside any units from the affected lot, complete and return the provided Acknowledgement Form directly to Cordis via fax (614-495-5571) or email to GMB-FieldCorrectiveAction@cardinalhealth.com. Customers were also instructed to arrange for return of affected product, provide the recall letter to personnel at your facility who need to be made aware and any other facility that may have been sent the affected units.

2000 Vascular with 30 Degree option

Potential for bed to drop suddenly at the head while a patient is laying on it.

Heritage Medical Products, Inc. notified customers on about 09/02/2016 via "Advisory Notice." Customers were informed that Heritage Medical has designed a reinforcement kit as a correction, which will be supplied to customers. Customers were instructed to contact Heritage Medical, provide the serial number of their bed to ensure it is affected, and Heritage Medical will provide a free kit that will reinforce the area on the affected devices that has experienced failures. The contact information is a follows: Heritage Medical Products, Inc., ATTN.: Trunnion Reinforcement Kit, 10380 CR 6310, West Plains, MO 65775, (888) 256-8748.

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSG

Pre-procedural issues related to software defects

Consignees were sent recall notification letters on approximately 10/11/2017. The letter identified the affected product, problem and actions to be taken. instructions included coordination with the respective Edwards representative to schedule the software upgrade.

Microsurgical Operating Room Tables;7300B (18-350-70);

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

The firm's representatives notified their U.S. consignees regarding the recall notification by phone and a separate FedEx letter was sent (08/09/2019 - date the letter was issued). The Customer Notification Letter "IMPORTANT VOLUNTARY RECALL NOTIFICATION", informed customers of the two (2) types of errors: 1) Unintended Tilting of the Tabletop - Impurities in the hydraulic oil has caused minor leaking inside a control valve causing the table to tilt after remaining static for long periods of time. 2) Incorrect Operation due to Infrared Operating Signal Errors - The table can inadvertently mix infrared signals from the hand pendant while using in the wireless mode and may cause unintended movement. Customer are also being informed that a sales representative will contact them to organize the logistics of the correction for the tables. The recall notification includes to visit the firm's webpage (www.mizuho.com) to find additional information related to the recall. For additional questions, the Customer Service Group or local sales representatives can be contacted.

BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.

Initial contact to customers was by telephone and visit on 18 October 2019. The firm followed with a letter disseminated by email on 10/25/2019. The firm is seeking return of the affected units and will replace them with correct devices.

COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).

The firm initiated the recall by letter in Europe on 18-December-2018 and 20-December-2018. The notices were sent in Japan today, 21-December-2018. The letter requested recall to the user level and return of the affected product.