2024 Product Recalls

3/4" Diced Tomatoes in Juice packed in 55 gallon metal drums

Foreign object; plastic

Eban's Bakehouse Sweet Indulgences - Lemon Sugar Cookie/Lemon Shortbread (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.

Undeclared Allergens - Milk and Soy

1/2" Diced Tomatoes in Juice packed in 55 gallon fiber drums

Foreign object; plastic

3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

Potential for breakage of the ECG electrode carbon stud from the eyelet.

The recalling firm, 3M Company, issued "Urgent - Medical Device Recall" letters dated 29 September 2021 to the distributors on 10/6/2021. The letter informs them of the issue and instructs them to immediately discontinue distribution of the affected lots and determine if any are in inventory. The affected product is to be destroyed by the distributor. The distributor is to notify any customers who have purchased the affected lots by using the enclosed Customer Letter and Customer Acknowledgment Form provided. The enclosed customer letter to be sent to the distributor's customers is dated 29 September 2021 and informs the customer of the issue. The customer is instructed to screen their facility or other storage locations to ensure all affected lots of the product are identified. They are to immediately cease use of affected lots of product and quarantine it for destruction/disposal. The customer is requested to pass the notification along to all who need to be aware within their organization or to any department where the affected product was transferred.Complete the attached Customer Acknowledgement Form with the following: o Acknowledge that you have read and understood this letter, whether or not you have any affected lots of the 3M" Red Dot" Radiolucent Monitoring Electrodes with Foam Tape, Catalog Number 2244 in stock at your facility; and o Indicate if you have any product in stock and dispose of this material per facility policy. o Email the completed form to 3MFieldSafetyAction@montage72.com. " Complete and return the Customer Acknowledgement Form to 3M even if your stock of affected lots of this product have been exhausted. " To request product replacement for affected lots requiring disposal, contact 3M Health Care Customer Helpline at 1-800-228-3957, option #7 or by email to 3MFieldSafetyAction@montage72.com. If you have questions regarding this matter, please contact your local 3M sales representative or the 3M Health Care Customer Hel

PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.

The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.

The recalling firm issued recall letters dated 10/10/2022 via email and overnight mail on 10/10/2022. The letter identified the product, the reason for recall and requested return of the affected lot as soon as possible. A return label was enclosed for return of product. A Customer Acknowledgment form was enclosed for return via email to report the quantity of product being returned. The form also asked the consignee if they remembered any used trays containing the 2ml ampule 0.75% Spinal Marcaine instead of the tray containing a 10ml ampule 0.9% Sodium Chloride. If the answer was yes, the consignee was to report whether the Marcaine was used and were there any adverse outcomes.

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

On 01/12/2021, DePuy Synthes issued an Urgent Medical Device Recall (removal) via letter due to taper dimensions of certain Universal Femoral Sleeves may be out of specification. The Universal Femoral Sleeves are used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. DePuy is recommending that customers return the recalled devices.

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

The firm sent out the recall notification to the consignees on 04/11/2022 via email. The letter instructs the users to avoid using the product and forward the notice to any affected users. The letter directed to the distributors instructs them to stop distribution of the product, send the notice to users of the product, and send a report to the manufacturer conforming inventory and contact information for each site that was contacted.

BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178

Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.

In April, 2021, Philips issued an Urgent Medical Device Removal notice to customers via letter notifying them that Philips determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. ACTION TO BE TAKEN BY CUSTOMER / USER 1. Locate all impacted devices listed above immediately STOP USE. All impacted devices must be removed from service. Replace with a non-impacted device if it is being used by a patient. 2. This notice needs to be passed on to all those who must be aware within your organization or to any organization where the impacted devices have been transferred. 3. Once impacted devices have been removed from service and isolated notify your Philips Representative that the impacted devices are ready for return. Your Philips Representative will arrange for return of the device. Replacements will be provided free of charge. 4. Fill out the Business Reply Form that has been provided with this letter and return it to your Philips Representative. This form serves as official acknowledgement that you have fully performed your obligations to complete this medical device recall.

Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming

The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees.

Eban's Bakehouse Sweet Indulgences - Variety Pack (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.

Undeclared Allergens - Milk and Soy

Shiloh Farms Organic 7 Grain Bread UPC 0-47593-02112-8

Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.

Maple Nut Fudge, 8oz, packaged in clear, plastic clamshell.

Undeclared egg

Cab Mirror Assembly May Detach

A detached mirror glass can reduce driver visibility, increasing the risk of a crash.

Dealers will inspect the mirror glass lock ring and repair it as necessary, free of charge. Owner letters were mailed February 23, 2024. Owners may contact Kenworth customer service at 1-425-828-5888 and/or Peterbilt customer service at 1-940-591-4220. PACCAR's numbers for this recall are 24KWA and 24PBA.

Loss of Power Steering Assist

The incorrectly machined bracket may cause a reduction in hydraulic force, requiring greater steering effort and increasing the risk of a crash.

Dealers will inspect and replace the steering assist bracket, free of charge. Owner notification letters were mailed February 7, 2024. Owners may contact E-One customer service at 1-352-237-1122.

GM Helix Acqua Implant 3.5x10, Article No. 140.944

3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.

The firm initially contacted affected customers by phone on October 11, 2021. Customers were instructed to immediately stop using the product and to place all impacted product in quarantine. The firm then followed up with a confirmation letter sent by UPS on October 22, 2021. Customers were instructed to identify and segregate the affected units, open or closed, in their stock. Product is to be returned to the manufacturer.' If product has been installed and the patient reports an issue (such as numbness, pain, or other symptoms), please notify the distributor immediately to receive instructions on how to proceed.

SOMATOM Force with software syngo.CT VB20 Model #10742326

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (CSAN) to customers via CT021/21/S on 8/30/2021. The CSAN informs the customer of the issues health risk, the new software update version VB20_SP5 to eliminate the root causes of these problems. The software update will be distributed free of charge via CT020/21/S and CT071/21/S (update is dependent on the current software version) to all affected customers. Action to take: Siemens Healthineers has developed software update syngo.CT VB20 SP5. This new software contains workflow improvements and solutions to the previously described software issues. Please ask your local service organization if you are interested in more detailed information about the content of the software update. The new software, VB20_SP5, will be provided free of charge and will be distributed via Update CT020/21/S or CT071/20/S. Update CT071/20/S is only necessary if the system is being updated from software version VB20, VB20_SP1, or VB20_SP2 directly to VB20_SP5. Following the corrective action process CAPA, the cause of identified product issues has been eliminated and a recurrence of the identified issues is prevented. This update will be performed remotely. The remote software updates process will require approximately 45 minutes for completion and is completely automatic; however, please make sure the system and power are stable before and during the process, please 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 you have any questions, please contact our service organization at at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Distributed product did not undergo proper release testing.

All consignees were contacted beginning 02/25/2022 via email. Consignees should read the recall instructions and determine if the product can be used or discarded, depending on user's lab procedures. A response form should be completed and returned to recall@microbiologics.com.

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

Microbiologics notified customers on 03/03/2022 via letter titled "Urgent Medical Device Recall Re: 8244 Pneumonia (33 Targets) Control Panel". Instructions included to review lab procedures to understand how the information affects usage, discard expired product, complete the response form provided, return the response form to recall@microbiologics.com, and keep the letter for consignees' records. Questions or concerns can be directed to the Recall Support team at 320.229.7073 or recall@microbiologics.com.

KWIK-STIK" plus: Clostridium perfringens

Labeling error.

The firm issued a recall notification to the consignees beginning on 05/06/2022 via email. The letter informs the consignee to inspect inventory, review lab procedures, use or discard affected product depending on lab procedures, and complete the response form.

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.

The firm sent out a recall notification to the distributors on 05/04/2022 via email. Phone calls were also made to the distributors. Additionally, the US field communication letter was mailed to the surgeon and facility in regard to the one case of implantation on May 10, 2022. The consignee letter informed the consignee to cease use and distribution of the affected product, check inventory for affected product, complete the response form, return affected product and notify affected consignees. The field surgeon letter and hospital letter informs the consignee to cease use and distribution of the affected product, monitor patients per normal protocol, return affected product and sign and return the response form.