FDA Recall Open, Classified

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

Recall: Z-1060-2022 · Initiated April 5, 2022

Recall

Recall Number: Z-1060-2022
Event Number: 89920
Firm: Certified Safety Mfg Inc
FEI Number: 1000158435
Product Code: LRR
Status: Open, Classified
Root Cause: Nonconforming Material/Component
Initiated: April 5, 2022
Address: 1400 Chestnut Ave, Kansas City, MO, 64127-2023

Description

Reason

First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.

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.

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.

Quantity

14,685 kits