Device product
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Z-0211-2022
Product summary
- Firm
- Z-Medica, LLC
- Event
- Event 88818
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2400 units
- Official record key
device-enforcement:Z-0211-2022
Official wording
Reason: Lack of Packaging seal integrity may result in a sterile barrier breach.
Code information: Lot# 12645 UDI I Primary DI Number: 00841495102004
Distribution pattern: US Nationwide distribution in the state of NC.
Derived failure modes
-
Labeling or packaging
Packaging seal integrity may result in a sterile barrier breach
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Sterility assurance
sterile barrier breach