QuikClot TraumaPad recalled over laceration hazard

Recall date

November 17, 2017

Source

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

Official notice title

Z-Medica, LLC recalls QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and…

Recall number

Z-0925-2018

FDA classification

Class II

Brand / firm

Z-Medica, LLC

Sold / distributed

Nationally

Why it was recalled

A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (QuikClot TraumaPad).

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, Part# 460 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