Drug recall
QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts…
FDA recall event 79407 · Class II · Z-Medica, LLC
Key facts
| Event ID | 79407 |
|---|---|
| Recall numbers | Z-0925-2018 |
| Recalling firm | Z-Medica, LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 17, 2017 |
| Report date | Mar 14, 2018 |
| Termination date | Jun 4, 2018 |
| City | Wallingford |
| State | CT |
| Country | United States |
| FEI number | 3004138549 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: