Recall Z-2612-2017— Z-Medica, LLC

Name: FDA recall Z-2612-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-17

Class II · Terminated

Class II FDA medical device recall by Z-Medica, LLC, initiated 2017-05-17, terminated 2018-06-15. It names one FDA 510(k) clearance: K123387. 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: Packaging breach may compromise sterility.

Recalling firm: Z-Medica, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-05-17
Terminated: 2018-06-15
Firm location: Wallingford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K123387 — QUIKCLOT HEMOSTATIC DRESSINGZ-Medica, LLC·cleared 2013-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.