Recall Z-3018-2020 ยท FQM Bandage, Elastic
North American Rescue LLC.
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 Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Ai
| Date | Aug 21, 2020 |
| Status | Terminated |
| Reason | Lack of sterility assurance of the 30-0171 |
| Root cause | Under Investigation by firm |
| Action | North American Rescue issued an urgent medical device recall notice on August 25,2020. It state the following: This recall is only for 30-0171 NAR Responder 4" Flat Emergency Trauma Dressing. All other components packaged in the first aid kit are not affected by this recall. 1. Examine your inventory and quarantine all product and kits identified in this recall notification. 2. Discontinue all distribution or use of the recalled products identified in the recall notification. 3. Identify the 30-0171 and verify the recalled lot TSD2419 or TS00320. 4. Remove the recalled lot TS02419 or TSD0 |
| Quantity | 11404 each |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.