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Terminated

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

FDA Recall Z-2612-2017 · Posted None

Recalling FirmZ-Medica, LLC
Recall StatusTerminated
Product CodeFRO
Date Initiated2017-05-17
Date Terminated2018-06-15
Product Quantity2910 pieces

Reason for Recall

Packaging breach may compromise sterility

Firm Action

Z- Medica issued recall letters dated May 15, 2017, on May 17 2017, advising users of the problem and requesting customers to check their inventory and return product for replacement. Distributors requested to sub recall. Customers with questions were instructed to contact (203) 774-5686.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123387QUIKCLOT HEMOSTATIC DRESSINGZ-Medica, LLC · 2013-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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