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 | 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). |
| 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 |
| Quantity | 4890 |
| Distribution | Nationally |
| Initiated | 2017-11-17 |
| Classified | 2018-03-08 |
| Terminated | 2018-06-04 |
| Recall number | Z-0925-2018 |
| 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-0925-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79407/
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