Device product
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Z-1548-2022
Product summary
- Event
- Event 90625
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 cases (125 eaches )
- Official record key
device-enforcement:Z-1548-2022
Official wording
Reason: Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Code information: UDI-DI Number: 50649111317590 Case 10649111317590 Kit Lot Numbers: 600001 600002
Distribution pattern: US Nationwide distribution in the states of FL, PA.
Derived failure modes
-
Labeling or packaging
mislabeled