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U.S. Department of Health and Human Services

Class 2 Device Recall first aid kit

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  Class 2 Device Recall first aid kit see related information
Date Initiated by Firm August 17, 2006
Date Posted November 02, 2006
Recall Status1 Terminated 3 on April 08, 2011
Recall Number Z-0145-2007
Recall Event ID 36566
Product Classification first aid kit - Product Code LRR
Product First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other first aid supplies, various sizes, - travel size, all purpose, first aid response kit, on-the-road, recreational, outdoor. First Aid Only, Inc. Vancouver, WA
Code Information Kit codes C-0054, C-0094, C-0104, C-0114, C-0124, C-0154, C-0164, C-0174, C-0184, C-0194, C-0224, C-0234, C-0244, C-0294, C-0304, C-0294, C-0164, B-0264, C-0314, C-0104, C-0224, C-0314, C-0104, C-0294, D-0024, D-0064, D-0084, D-0134, D-0264, C-0104, C-0094, E-0134, F-0074, G-0194  Acetaminophen coded 03M847, expiration 12/06
Recalling Firm/
Manufacturer
First Aid Only Inc
11101 Ne 37th Cir
Vancouver WA 98682-7218
For Additional Information Contact Gale Hutchinson
360-448-6252
Manufacturer Reason
for Recall
Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.
FDA Determined
Cause 2
Other
Action The firm issued a letter dated August 17, 2006 to their customers advising of the recall and requesting product be removed from retail level and returned to the firm.
Quantity in Commerce 365,298 total kits of all brands
Distribution Kits were distributed nationwide to distributors, retailers and to one international distributor.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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