Z-1323-2024 Class I Ongoing
FDA device recall Z-1323-2024 was initiated by Fresenius Medical Care Holdings, Inc. on Jan 23, 2024 and is designated Class I. Reason for recall: The peroxide cross-linked tubing has leachables identified as NDL PCBAs. The recall status is ongoing. Affected quantity: 114,982 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2024
- Initiation Date
- Jan 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114,982 eaches
Product Description
stay-safe /Safe Lock Catheter Ext. 12 in
Reason for Recall
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Distribution Pattern
Domestic: Nationwide Distribution.
Code Information
Model Number: 050-95001; UDI/DI (Bag): 00840861100767; UDI/DI (Case): 10840861100764; All lots.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1323-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026