Stay-Safe Safe Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
stay-safe /Safe Lock Catheter Ext. 12 in
Brand
Fresenius Medical Care Holdings, Inc.
Lot Codes / Batch Numbers
Model Number: 050-95001, UDI/DI (Bag): 00840861100767, UDI/DI (Case): 10840861100764, All lots.
Products Sold
Model Number: 050-95001; UDI/DI (Bag): 00840861100767; UDI/DI (Case): 10840861100764; All lots.
Fresenius Medical Care Holdings, Inc. is recalling stay-safe /Safe Lock Catheter Ext. 12 in due to The peroxide cross-linked tubing has leachables identified as NDL PCBAs.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026