FDA Device recall Z-2612-2017
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield…
- FDA Device
- Class II
- terminated
- Published 2017-06-28
On 2017-06-28 the FDA classified a Class II recall of QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield… by Z Medica, citing packaging breach may compromise sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2612-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-17 |
| Published | 2017-06-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Z Medica |
| Distribution | US |
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
Packaging breach may compromise sterility
Identifiers
| code_info | Lot # 7313 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2612-2017%22
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