QuikClot TraumaPad — Class II medical device recall Z-2612-2017
Terminated recall by Z-Medica, LLC, reported 2017-06-28, distributed nationwide. Packaging breach may compromise sterility
| Recall number | Z-2612-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Z-Medica, LLC, Wallingford, CT, United States |
| Recall initiated | 2017-05-17 |
| Classified | 2017-06-19 |
| Reported by FDA | 2017-06-28 |
| Terminated | 2018-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR, TH, TW |
| Quantity | 2,910 units |
| Reason classes | sterility |
| Lot numbers | 7313 |
| Model numbers | 460 |
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
Reason for recall
Packaging breach may compromise sterility
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-2612-2017. 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.