Recall Z-1327-2024 · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Catheter Ext. 6 in
| Date | Mar 26, 2024 (initiated Jan 23, 2024) |
| Status | Open, Classified |
| Reason | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 105,700 eaches |
| Distribution | Domestic: Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022412 | FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR Fresenius Medical Care North America, Mar 5, 2003 |
| K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, stay Fresenius Medical Care Renal Therapies Group, LLC, May 21, 2018 |