Device product
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
Z-1551-2022
Product summary
- Event
- Event 90625
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,169 cases (125,070 eaches)
- Official record key
device-enforcement:Z-1551-2022
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: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019
Distribution pattern: US Nationwide distribution in the states of FL, PA.
Derived failure modes
-
Labeling or packaging
mislabeled