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U.S. Department of Health and Human Services

Class 2 Device Recall First aid kits and cabinets

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  Class 2 Device Recall First aid kits and cabinets see related information
Date Initiated by Firm April 05, 2022
Create Date May 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-1060-2022
Recall Event ID 89920
510(K)Number K940249  
Product Classification First Aid Kit with drug - Product Code LRR
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
Code Information 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.
Recalling Firm/
Manufacturer		 Certified Safety Mfg Inc
1400 Chestnut Ave
Kansas City MO 64127-2023
For Additional Information Contact Mr. Pam Gerson
800-854-7474
Manufacturer Reason
for Recall		 First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LRR and Original Applicant = CERTIFIED SAFETY MFG., INC.
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