Z-2612-2017 Class II Terminated

Recalled by Z-Medica, LLC — Wallingford, CT

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