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; (8) KR618-016 EMTR - Duke Energy TD - Refill; (9) K616-008 FAC-3 - Class B + Meds - 3 Shelf Cabinet; (10) KR616-008 FAC-3R - Class B + Meds - Refill; (11) K618-013 FAC-3 - Five Star Safety - w/Logo; (12) K611-044 FAC-3 - Uline 100 person - w/Logo; (13) K620-609 FAC-3 - Uline Class B + Meds - w/Logo; (14) K616-072 FAC-4 - Choate Construction - w/Logo; (15) KR616-072 FAC-4R - Choate Construction - Refill; (16) K616-066 FAC-4 - Class B + Meds - 4 Shelf Cabinet; (17) KR616-066 FAC-4R - Class B + Meds - Refill; (18) K612-159 FAC-4 - Uline - w/Logo - w/Contents sticker; (19) K616-067 FAC-5 - Class B - 5 Shelf Cabinet; (20 KR616-067 FAC-5R - Class B - Refill
- Company
- Certified Safety Mfg Inc
- Recall Initiated
- April 5, 2022
- Recall Number
- Z-1060-2022
- Quantity
- 14,685 kits
- Firm Location
- Kansas City, MO
Reason for Recall
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
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.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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 returned and the option they took for notification of downstream customers. The response form was to be returned via email or FAX to the recalling firm.