Class II — Z-Medica, LLC
| Recalling firm | Z-MEDICA, LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Packaging breach may compromise sterility |
| 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 |
| Quantity | 2910 pieces |
| Distribution | Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand |
| Initiated | 2017-05-17 |
| Classified | 2017-06-19 |
| Terminated | 2018-06-15 |
| Recall number | Z-2612-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Z-Medica, LLC (Z-2612-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77316/
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