Recall Z-1324-2024— Fresenius Medical Care Holdings, Inc.
Class I · Ongoing
Class I FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2024-01-23. It names 2 FDA 510(k) clearances: K173593, K022412. Product: stay-safe /Luer Lock Adapter 4 in. Reason: The peroxide cross-linked tubing has leachables identified as NDL PCBAs..
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-01-23
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
- K022412 — FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
stay-safe /Luer Lock Adapter 4 in
Reason for recall
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.