QuikClot TraumaPad recalled over laceration hazard

Recall date

May 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Z-Medica, LLC recalls QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medi…

Recall number

Z-2612-2017

FDA classification

Class II

Brand / firm

Z-Medica, LLC

Sold / distributed

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

Why it was recalled

Packaging breach may compromise sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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