Z-2612-2017 Class II Terminated
FDA device recall Z-2612-2017 was initiated by Z-Medica, LLC on May 17, 2017 and is designated Class II. Reason for recall: Packaging breach may compromise sterility The recall status is terminated (terminated June 15, 2018). Affected quantity: 2910 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2017
- Initiation Date
- May 17, 2017
- Termination Date
- June 15, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2910 pieces
Product Description
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
Reason for Recall
Packaging breach may compromise sterility
Distribution Pattern
Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
Code Information
Lot # 7313