FDA recall Z-2612-2017

Product

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

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

Key facts

Status

Terminated

Initiation date

2017-05-17

Report date

2017-06-28

Termination date

2018-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wallingford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2612-2017