Recall Z-0925-2018— Z-Medica, LLC

Name: FDA recall Z-0925-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-17

Class II · Terminated

Class II FDA medical device recall by Z-Medica, LLC, initiated 2017-11-17, terminated 2018-06-04. It names one FDA 510(k) clearance: K123387. Product: 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. Reason: 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)..

Recalling firm: Z-Medica, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Terminated: 2018-06-04
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, 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

Reason for recall

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).

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