Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1060-2022·Announced 2022-05-18

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Certified Safety Mfg Inc
Category: Medical Device — First Aid Kits and Cabinets
Hazard: manufacturing-deviation
Affected units: 14,685

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:

Same manufacturer · Certified Safety Mfg Inc

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