Z-2612-2017Class II

QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured...

Name: Z-2612-2017 QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured...
Creator: Z-Medica, LLC
Published: 2017-05-17
License: https://open.fda.gov/license/

Z-Medica, LLC / initiated 2017-05-17 / Terminated / root cause: packaging

FDA source

Z-Medica, LLC began a recall of QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard... on 2017-05-17. FDA classified it as Class II and gives the reason as "Packaging breach may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2612-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-17
Posted: 2017-06-19
Terminated: 2018-06-15
Recalling firm: Z-Medica, LLC
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
Product code: FRO Dressing, Wound, Drug
Reason for recall: Packaging breach may compromise sterility
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Z- Medica issued recall letters dated May 15, 2017, on May 17 2017, advising users of the problem and requesting customers to check their inventory and return product for replacement. Distributors requested to sub recall. Customers with questions were instructed to contact (203) 774-5686.
Quantity in commerce: 2910 pieces
Distribution: Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
Product codes and lots: Lot # 7313

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2612-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2612-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-19

Product code FRO

K123387UnclassifiedQuikclot Hemostatic DressingZ-Medica, LLC / cleared 2013-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)