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Class 2 Device Recall first aid kit |
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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
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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
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For Additional Information Contact |
Gale Hutchinson 360-448-6252
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Manufacturer Reason for Recall |
Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.
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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
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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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