Device product
stay-safe /Safe Lock Catheter Ext. 12 in
Z-1323-2024
Product summary
- Event
- Event 94084
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 114,982 eaches
- Official record key
device-enforcement:Z-1323-2024
Official wording
Reason: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Code information: Model Number: 050-95001; UDI/DI (Bag): 00840861100767; UDI/DI (Case): 10840861100764; All lots.
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Unknown
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.