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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89920

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 05, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Certified Safety Mfg Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1060-2022
Recall number
Z-1060-2022
Initiated
April 05, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Certified Safety Mfg Inc
Quantity
14,685 kits

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

Distribution pattern

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.