Device product
Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
Z-1549-2022
Product summary
- Event
- Event 90625
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,513 cases (45,390 eaches)
- Official record key
device-enforcement:Z-1549-2022
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: 10850007185760 Case 00850007185763 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600006 600007 600008
Distribution pattern: US Nationwide distribution in the states of FL, PA.
Derived failure modes
-
Labeling or packaging
mislabeled