First Aid Kits and Cabinets Recalled for Manufacturing Deviations
Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall due to manufacturing practice deviations without reported illnesses or injuries. The hazard is precautionary in nature pending investigation of the manufacturing compliance issues.
Plain-English summary
Certified Safety Mfg Inc is recalling first aid kits and cabinets that contain Medi-First XS Non-Aspirin and Medi-First Sinus Pain & Pressure medication components. The recall was initiated because the medication components were supplied by a manufacturer with current good manufacturing practice (cGMP) deviations.
Approximately 14,685 kits were distributed across 34 U.S. states: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming. There was no distribution to foreign, military, or government entities.
Consumers and healthcare facilities that possess these kits or cabinets should contact Certified Safety Mfg Inc or their supplier for recall instructions. Specific product kit numbers and medication lot numbers are documented with the FDA.
The recalled product
- 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 - Fir
- Manufacturer
- Certified Safety Mfg Inc
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Component packet and box lot numbers: Medi-First XS Non-Aspirin
- Product #80450 - Packet lot #6348
- box lot #'s 7572 and 7971
- packet lot #6529
- box lot #08834. Medi-First Sinus Pain & Pressure
- Product #81950 - Packet lot #6139
- box lot #6935
- packet lot #6428
- box lot #'s 07332 and 07046
- packet lot #6558
- box lot #'s 07768
- 07741
- and 07779
- packet lot #6583
- box lot #08281
- packet lot #6641
- (2) Product #KR616-006 - (01) 00 7 66588 16006 1
- (3) Product #KR616-015 and #K616-015 - (01) 00 7 66588 16015 3
- (4) Product #K618-016 and #KR618-016 - (01) 00 7 66588 18016 8
- (5) Product #K616-008 and #KR616-008 - (01) 00 7 66588 16008 5
Distribution
Distributed in 36 states:
- 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
- WY
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