Drug recall
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a)…
FDA recall event 86340 · Class II · North American Rescue LLC.
Key facts
| Event ID | 86340 |
|---|---|
| Recall numbers | Z-3018-2020 |
| Recalling firm | North American Rescue LLC. |
| Product type | Devices |
| Products | 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of sterility assurance of the 30-0171 |
| Initiation date | Aug 21, 2020 |
| Report date | Oct 7, 2020 |
| Termination date | Jan 31, 2024 |
| City | Greer |
| State | SC |
| Country | United States |
| FEI number | 3005034064 |
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: