Z-0853-2008

First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and...

Name: Z-0853-2008 First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and...
Creator: First Aid Only Inc
Published: 2007-12-10
License: https://open.fda.gov/license/

Acme United Corp. / initiated 2007-12-10 / Terminated / root cause: manufacturing process

FDA source

First Aid Only Inc began a recall of First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits... on 2007-12-10. The reason FDA records is "Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0853-2008
Status: Terminated
Initiated: 2007-12-10
Posted: 2008-02-19
Terminated: 2011-04-08
Recalling firm: Acme United Corp.
Product: First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits include: Labeled with First Aid Only, Inc. Vancouver, WA: Recreational Sports First Aid, Item SM-134; Welder's First Aid Kit, Item 253-U; Vehicle First Aid Kit, Item 220-0; On-The-Road Auto First Aid, Item FAO-310; Auto First Aid Essentials, Item FAO-340; Auto First Aid Essentials, Item FDA-532; Auto First Aid Essentials, Item FDA-552; Vehicle First Aid Kit, Item 221-U; Outdoor First Aid Kit, Item FAO-410; Outdoor First Aid Kit, Item FAO-410 Outdoor First Aid Kit, Item FAO-420; Outdoor First Aid Kit, Item FAO-430; Outdoor First Aid Kit, Item FAO-440; First Aid & Survival Kit, Item FA-462; First Aid Kit, FAO-422-06; First Aid Kit, 403-PC; First Aid Response Kit, FA-504; All Purpose First Aid Kit, Item FAO-112; All Purpose First Aid Kit, Item FAO-122; All Purpose First Aid Kit, Item FAO-142; All Purpose First Aid Kit, Item FAO-432; All Purpose First Aid Kit, Item FAO-444; All Purpose First Aid Kit, Item FAO-452; First Aid Essentials, Item FAO-130; First Aid Essentials, Item FAO-132; First Aid Essentials, Item FAO-134; First Aid Essentials, Item FAO-422; First Aid Essentials, Item FAO-428; First Aid Essentials, Item FAO-432; First Aid Essentials, Item FAO-442; Refillable First Aid Kit, FAO-490C; Refillable First Aid Kit, FAO-490C; Brite Stock first aid kits (only labeled on shipping case as being manufactured by First Aid Only): Item FAO-130-BS; Item FAO-132-BS; Item FAO-134-BS; Manufactured by First Aid Only, Inc. Vancouver, WA. Distributed by Wholesale Merchandisers, Inc., Grand Rapids, MI 49544: Lake & Trail Outdoor First Aid Kit, Item MJR-420; Lake & Trail Outdoor First Aid Kit, Item MJR440; First aid kits labeled DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544: meijer First Aid Kit, Item MJR-130; meijer First Aid Kit, Item MJR-442; First Aid Kits labeled FIRST AID Exchange: General Purpose Home First Aid Kit, Item 2800; Auto First Aid Kit, Item 2825 First Aid Kit labeled Distributed by Medicine Shoppe International St. Louis, MO: All purpose First Aid Kit, Item FAO-132-MS First Aid Kit labeled Mfg. by First Aid Only, Inc. Vancouver, WA Ready Solutions: First Aid Kit, Item 90030 First Aid Kit labeled NORTHERN Safety Co., Inc.: First Aid Kit, Item FAO-442-NS First Aid Kit labeled Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30060: Grafco First Aid Kit, Item 1799-9133 and First Aid Kit labeled -Provided by MOTURIS LTD- Custom Kit, Item 9099
Product code: LRR First Aid Kit With Drug
Reason for recall: Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm issued an Urgent Device Recall letter dated 10/10/07 to consignees receiving any of the products. The letter instructs consignees to return any recalled product to the firm. If any recalled prdoucts were further distributed, the consignee was requested to notify those consignees and have product returned.
Quantity in commerce: 72,904 kits
Distribution: Worldwide: USA and to one distributor in Dubai, United Arab Emirates.
Product codes and lots: Lot Numbers are for kits and cabinets: C0207, C0217, C0227, C0267, C0277, C0287, C0297, C0307, D0027, D0037, D0047, D0057, D0067, D0097, D0107, D0117, D0127, D0137, D0167, D0177, D0187, D0197, D0207, D0247, D0267, E0027, E0047, E0077, E0087, E0177, E0187, D0227, E0297, E0307, E0317, F0017, F0087, F0207, F0267, G0067, G0097, G0137, G0187, G0257, H0017, H0157, H0167, H0237, H0277, H0287, H0297, H0307, H0317, I0047, I0057, I0107, I0127, I0137, I0177, I0187, I0197, I0207, I0217, I0247, I0251, I0277, I0287, J0017, J0037, J0047, J0087, J0097, and J0117.

Product code LRR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)