Class 2 Device Recall first aid kit

• Date Initiated by Firm: August 17, 2006
• Date Posted: November 02, 2006
• Recall Status: Terminated on April 08, 2011
• Recall Number: Z-0147-2007
• Recall Event ID: 36566
• Product Classification: first aid kit - Product Code LRR
• Product: First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a variety of first aid supplies. Made in U.S.A. for 3M 3M Consumer Health Care St. Paul, MN 55144-1000
• Code Information: Kit code C-0234, C-0244, C-0254, C-0264 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: 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.