Device product
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
Z-2612-2017
Product summary
- Firm
- Z-Medica, LLC
- Event
- Event 77316
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2910 pieces
- Official record key
device-enforcement:Z-2612-2017
Official wording
Reason: Packaging breach may compromise sterility
Code information: Lot # 7313
Distribution pattern: Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
Derived failure modes
-
Sterility assurance
Packaging breach may compromise sterility