Device product
stay-safe /Luer Catheter Ext. 6 in
Z-1327-2024
Product summary
- Event
- Event 94084
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 105,700 eaches
- Official record key
device-enforcement:Z-1327-2024
Official wording
Reason: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Code information: Model Number: 050-95013; UDI/DI (Bag): 00840861100804; UDI/DI (Case): 10840861100801; All lots.
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Unknown
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.