2023 Product Recalls

Partition Wall May Detach

A detached partition wall can increase the risk of injury.

Dealers will inspect and secure the partition wall as necessary, free of charge. Owner notification letters are expected to be mailed February 16, 2024. Owners may contact DVUSA customer service at 1-877-762-8267. DVUSA's number for this recall is VS3TREWAN.

Missing Frame Member Reinforcement Fasteners

Reduced stability increases the risk of a crash. Additionally, the third-row seat mountings can fail, increasing the risk of injury during a crash.

Dealers will inspect and repair the frame members as necessary, free of charge. Owner notification letters were mailed March 4, 2024. Owners may contact DVUSA customer service at 1-877-762-8267. DVUSA's number for this recall is VS3ROHRAH.

Crossmember Connection May Loosen

Reduced vehicle control increases the risk of a crash. Additionally, the propeller shaft may damage the fuel tank during a crash, causing a leak and increasing the risk of a fire.

Dealers will inspect and replace the crossmember as necessary, free of charge. Owner notification letters were mailed April 19, 2024. Owners may contact DVUSA customer service at 1-877-762-8267. DVUSA's number for this recall is VS3QUERTR.

Overloaded Electrical System May Cause Fire

Overloaded electrical circuits can overheat, increasing the risk of fire.

Dealers will update the firmware, free of charge. Owner notification letters were mailed January 15, 2024. Owners may contact REV customer service at 1-855-661-9232.

Auto-Hold or Park May Not Activate as Intended

Failure to activate "auto-hold" or "park" can result in unintended vehicle movement, increasing the risk of a crash.

Rivian has released an over-the-air (OTA) software update. Rivian will also replace the accelerator pedals, free of charge. Owner notification letters were mailed January 18, 2024. Owners may contact Rivian customer service at 1-888-748-4261. Rivian's number for this recall is FSAM 1342.

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

Olympus issued Urgent Medical Device Correction letter dated 12/13/21. Letter states reason for recall, health risk and action to take: 1. Please immediately perform an inspection of your installed OER-Elite units as described in the Attachment 1 Alcohol Rinse Inspection . If you require assistance, please contact your local Endoscopy Support Specialist (ESS). 2. If the inspection check does not pass, stop using the OER-Elite and endoscopes reprocessed with that OER-Elite. Contact Olympus TAC at 1-800-848-9024, option 1 for further instruction. If the inspection check passes, you may continue to use your OER-Elite. 3. Access the Olympus recall portal to indicate that you have received this notification and to report the results of the inspection. Go to https://olympusamerica.com/recall. Enter the recall number "0404" and provide your contact information as indicated in the portal. An Olympus Endoscopy Support Specialist (ESS) will reach out to you to schedule an on-site inspection of the OER-Elite detergent and alcohol tubing assembly for final confirmation. If you do not know your local ESS, please contact our Olympus TAC at 1-800-848-9024 to connect you with your local ESS. In addition, if you have further distributed this product, please reach out to those facilities and notify them at once of this field action and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this field action notification letter. If you require additional information, please do not hesitate to contact me at Cynthia.Ow@Olympus.com.

CK MB Calibrator, Catalogue Number CK2393

Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.

Firm notified customers via email on March 25, 2022. The distributors and customers were instructed to discard previous target sheet and perform calibration with the realigned target value provided with the letter. Also, to complete and return the response form 12187-QA to technical.service@randox.com.

Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203), and Alaris Pump module Bezel Kit Assembly (P/N 10964559 and P/N 49000204). Product Usage: The Alaris Pump module is

The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.

On 04/20/18, the firm mailed Medical Device Recall Notification letters. Customers were advised that affected units outlined in the previous September 1, 2017 recall will now include affected devices with date codes September 2011 through December 2011. Customers were asked to remove the pump from use if there are signs of infusion at an unexpected rate. Use non-affected devices in high risk areas if possible. Consider having additional devices as back up until your affected devices are remediated. If the user experiences the issue described in this notification, clearly mark and sequester the devices from use and notify Support Center. Customers were asked to complete and return the Customer Response Cards to acknowledge receipt of the notification. Firm will contact all affected customers within 60 days to replace the mechanical assemblies on affected serial numbers at no charge. Customers experiencing the issue described in this notification are encouraged to call the Support Center at 888-562-6018 or email SupportCenter@carefusion.com. On 04/15/19 the firm mailed URGENT: Medical Device Recall Notification letters. Customers were advised that the firm will contact customers of Priority 1 pumps within 60 days of this notification to initiate scheduling of the inspection of those pumps. The firm will contact customers to schedule replacement of bezels in Priority 2 pumps once Priority 1 pumps have been addressed. Until the bezels affected by this recall are replaced by the firm, customers should inspect bezels of both Priority 1 and Priority 2 pumps during their annual preventative maintenance schedule. Any pumps with bezel post separation should be removed from service. The recalling firm will contact customers to schedule replacement of bezels in Priority 2 pumps once Priority 1 pumps have been addressed. Customers were asked to complete and return Customer Response Cards to acknowledge receipt of this notification. In addition to the Support Cente

Scanga Meat Company Recalls Ground Beef Products Due to Possible E. Coli O103 Contamination

Product Contamination

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.

The firm notified its consignees by email beginning 03/24/2020. The notice explained the issue, risk to health, and requested a response. Distributors/pharmacy suppliers were directed to notify their customers. The firm is seeking return of the units for correction.

ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

DePuy Synthesis issued Urgent Medical Device Recall Letter dated 1/5/22. Letter states reason for recall, health risk and action to take: 1. Carefully review the information contained in this notice. 2. Return the subject products using the normal returns process. Work with your sales consultant to ensure that the products are returned and to arrange for a replacement. To receive replacement product or reimbursement, customers must return the products subject to this notice. 3. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. The Business Response Form (BRF) must be completed and returned even if no subject product is in your possession. 4. Forward this notice to any personnel in your facility who need to be informed. 5. If any of the products subject to this notice have been forwarded to another facility, contact that facility and provide a copy of this notice to the relevant personnel. 6. Post a copy of this notice in a visible area for awareness of this notice. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda. If you have any questions, please contact your local DePuy Synthes Sales Consultant.

Improperly Bonded Body Panels

Reduced structural strength may not adequately protect passengers, increasing the risk of injury. Additionally, the fuel system may be damaged during a crash, causing a fuel leak and increasing the risk of a fire.

Dealers will install two rivets and apply sealant, free of charge. Owner notification letters were mailed February 8, 2024. Owners may contact Land Rover customer service at 1-800-637-6837. Land Rover's number for this recall is N837.