QuikClot TraumaPad — Class II medical device recall Z-0925-2018
Terminated recall by Z-Medica, LLC, reported 2018-03-14. A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot Tr
| Recall number | Z-0925-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Z-Medica, LLC, Wallingford, CT, United States |
| Recall initiated | 2017-11-17 |
| Classified | 2018-03-08 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-06-04 |
| Quantity | 4,890 |
| Lot numbers | 7397 |
| Model numbers | 460 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0925-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.