The following first aid kits and cabinets containing recall: CGMP Deviations
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus…
Why was The following first aid kits and cabinets containing recalled?
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, box lot #'s 08586 and 08684. First aid kits and cabinet UDI numbers: (1) Product #K616-033 - (01) 00 7 66588 16033 7; (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; (6) Product #K618-013 - (01) 00 7 66588 18013 7; (7) Product #K620-609 - (01) 00 7 66588 20609 7; (8) Product #K616-072 and #KR616-072 - (01) 00 7 66588 16072 6; (9) Product #K616-066 and #KR616-066 - (01) 00 7 66588 16066 5; and (10) Product #K616-067 and #KR616-067 - (01) 00 7 66588 16067 2.
- 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…
- Recalling firm
- Certified Safety Mfg Inc
- 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.
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)