Class II — Certified Safety Mfg Inc
| Recalling firm | CERTIFIED SAFETY MFG., INC. |
|---|---|
| Registered facility | CERTIFIED SAFETY MFG., INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer. |
| Product | 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; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill; (6) K616-015 75V - Class A Office - 3-Shelf Cabinet; (7) K618-016 EMT - Duke Energy TD - Red Bag; … |
| 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. |
| Initiated | 2022-04-05 |
| Classified | 2022-05-11 |
| Terminated | 2026-08-04 |
| Recall number | Z-1060-2022 |
| 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 — Certified Safety Mfg Inc (Z-1060-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89920/
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