Z-1060-2022Class II

The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2...

Name: Z-1060-2022 The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2...
Creator: Certified Safety Mfg Inc
Published: 2022-04-05
License: https://open.fda.gov/license/

Certified Safety Mfg Inc / initiated 2022-04-05 / Open, Classified / root cause: manufacturing process

FDA source

Certified Safety Mfg Inc began a recall of 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 &... on 2022-04-05. FDA classified it as Class II and gives the reason as "First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1060-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-05
Posted: 2022-05-11
Recalling firm: Certified Safety Mfg Inc
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; (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
Product code: LRR First Aid Kit With Drug
Reason for recall: First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1060-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1060-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-18	2022-05-11

Product code LRR

K940249Not classifiedCertiburn Burn/trauma Face Dressing /Towel DressingCertified Safety Mfg., Inc. / cleared 1994-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)