FDA Medical Device Recalls (openFDA)
Z-Medica, LLC: 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
- Recall number
- Z-0925-2018
- 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
- Status
- Terminated
- Initiated
- 2017-11-17
- Posted
- not on file
- Terminated
- 2018-06-04
- 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).
- 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
- 4890
- Distribution
- Nationally
- Lot, serial or model codes
- Part# 460, Lot# 7397
- 510(k) numbers
- ["K123387"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3004138549
- Firm city
- Wallingford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28