Recall Z-1060-2022 ยท LRR First Aid Kit With Drug
Certified Safety Mfg Inc
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal
| Date | Apr 5, 2022 |
| Status | Terminated |
| Reason | First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued recall letters dated 4/4/2022 via certified mail on 4/5/2022. The letter explained the reason for recall and requested they remove and return the affected Medi-First Extra Strength Non-Aspirin and Medi-First Sinus Pain & Pressure product from the first aid kits and cabinets listed in the letter. The letter requested the consignee either notify their customers who have received the affected first aid kits and cabinets or provide a customer list so the recalling firm can notify their customers. A response form was enclosed to indicate the amount of product being retu |
| Quantity | 14,685 kits |
| Distribution | Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, WI, WV, and WY. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING Certified Safety Mfg., Inc., Oct 3, 1994 |