Z-0925-2018Class II

QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts...

Name: Z-0925-2018 QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts...
Creator: Z-Medica, LLC
Published: 2017-11-17
License: https://open.fda.gov/license/

Z-Medica, LLC / initiated 2017-11-17 / Terminated / root cause: packaging

FDA source

Z-Medica, LLC began a recall of 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... on 2017-11-17. FDA classified it as Class II and gives the reason as "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...". 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-0925-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2018-03-08
Terminated: 2018-06-04
Recalling firm: Z-Medica, LLC
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
Product code: FRO Dressing, Wound, Drug
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).
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: On November 22, 2017 an URGENT ADVISORY NOTICE was issued to customers stating the following: The QuikClot TraumaPad is packaged with 10 pouches in a carton. This lot may contain some pouches that incorrectly identify the product as QuikClot Roll. All pouches (identified as TraumaPad or Roll) are identified with the correct Part N umber (REF 460), Lot Number, and Expiration Date for QuikClot TraumaPad, and contain the QuikClot TraumaPad product. Please note that the labeling on the cartons is also correct and we believe that this only impacts a small num ber of pouches. In addition, QuikClot TraumaPad and QuikCot Roll have the identical ingredients, chemical composition, indications for use, packaging material and surface area. The only difference is that the QuikClot TraumaPad is a 12 inch x 12 inch, 3-ply pad and the QuikClot Roll is a 3 inch x 4 yard roll. Both products are equally effective in being used to stop bleeding. This was the result of an isolated operator error. Please note that actions have been taken to prevent this issue in the future and further corrective actions are under review. Ifyou have any inventory of this lot number, you may choose to use the prod uct as the correct prod uct is packaged into each pouch (only pouch labeling is incorrect). Ifyou chose to destroy the prod uct or have any questions regardi ng this matter, please contact us at the email and telephone number below.
Quantity in commerce: 4890
Distribution: Nationally
Product codes and lots: Part# 460, Lot# 7397

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0925-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0925-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-08

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)