Recalls / —

—#206266

Product

stay-safe /Luer Lock Adapter 4 in

FDA product code

KDJ — Set, Administration, For Peritoneal Dialysis, Disposable

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K022412, K173593

Affected lot / code info

Model Number: 050-95003; UDI/DI (Bag): 00840861100774; UDI/DI (Case): 10840861100771; All lots.

Why it was recalled

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

Root cause (FDA determination)

Device Design

Action the firm took

IMPORTANT MEDICAL DEVICE CORRECTION Letter were sent to customer on February 14, 2024 informing customers that non-dioxin-like polychlorinated biphenyl acids (PCBAs) could leach from the stay-safe Catheter Extension sets and Adapter, which are manufactured using peroxide cross-linked silicone tubing. Please note that PCBAs are chemically different from polychlorinated biphenyls (PCBs) which were not identified. No complaints have been reported. PCBA levels decrease with shorter catheter extension sets and decrease over the treatment time. PCBA exposure threshold examples were provided per body weight (less than 10kg and between 10 and 40 kg), treatment length and various device combinations. Patients with body weight greater than 40kg are not impacted. FMCRTG recommends the following for Healthcare providers until an update to the catheter extension silicone material becomes available: 1. Use only the shortest length extension set (6-inch, Part No. 050-95013) when treating patients with a body weight below 40 kg, including infants and neonates. 2. Remain alert for further updates and recommendations from the FMCRTG and FDA. 3. Please report any complaints or adverse events to product.complaints@fmcna.com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safetyinformation/medwatch-forms-fda-safety-reporting. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309. ***Update 04/10/2024*** A revised Medical Device Correction Letter and Poster were sent to customers via email recommending the following for Healthcare providers until an update to the catheter extension silicone material becomes available: 1. Use only the shortest length extension set (6-inch, Part No. 050-95013) when treating patients with a body weight below 40 kg, including infants and Neonates and if possible, avoid using the adapter. This is for both existing patients and patients about to initiate peritoneal dialysis. Re

Recalling firm

Firm

Fresenius Medical Care Holdings, Inc.

Address

920 Winter St, Bld 920, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern

Domestic: Nationwide Distribution.

Timeline

Recall initiated

2024-01-23

Posted by FDA

2024-03-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206266. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.