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U.S. Department of Health and Human Services

Class 2 Device Recall ARC DISASTER KIT

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 Class 2 Device Recall ARC DISASTER KITsee related information
Date Initiated by FirmJuly 07, 2011
Date PostedOctober 27, 2011
Recall Status1 Terminated 3 on March 29, 2012
Recall NumberZ-0120-2012
Recall Event ID 60041
Product Classification First aid kit with drug - Product Code LRR
ProductARC DISASTER KIT (American Red Cross), Part Number 7201, UPC 0-91966-04708-6, The kit is labeled in parts: "***American Red Cross***Item 7201*** 2 IODINE PREP PADS***Produced by the American Red Cross***Oregon Trail Chapter***503-528-5848***PO Box 3200, Portland, OR 97208***www.RedCross.org***". First aid kit.
Code Information no codes.
Recalling Firm/
Manufacturer		 Lifeline First Aid LLC
26200 SW 95th Ave Ste 301
Wilsonville OR 97070-8204
For Additional Information ContactBryan O'Doherty
503-783-3653
Manufacturer Reason
for Recall		The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad.
FDA Determined
Cause 2		Material/Component Contamination
ActionLifeline First Aid, LLC sent a " PRODUCT RECALL NOTICE-LIFELINE FIRST AID KITS WHICH INCLUDE H & P [TRIAD] PVP IODINE WIPES" letter dated July 7, 2011 to all affected customers. The letter states that Lifeline First Aid, LLC has become aware of a recall of Povidone Iodine Wipes manufactured by H&P Industries Inc. (TRIAD GROUP) and marketed under various brand names, including Triad and Swift. The recall of the Povidone Iodine Wipe is due to potential microbial contamination of the product. The letter instructs customers to collect and quarantine all affected products and to complete and return an attached Customer Response Form via fax to (503) 783-3721. Affected products will be replaced without charge and acceptable Lifeline first aid kits will be re-worked and returned using Lifeline's standard RGA process. Customers may call Lifeline customer service at 1 (877) 377-8243 for further instructions.
Quantity in Commerce320 kits
DistributionNationwide Distribution
Total Product Life CycleTPLC 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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