Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0120-2012

ARC DISASTER KIT (American Red Cross), Part Number 7201, UPC 0-91966-04708-6, The kit is labeled in parts...

Lifeline First Aid LLC / initiated 2011-07-07 / Terminated / root cause: manufacturing process

Lifeline First Aid LLC began a recall of ARC 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... on . The reason FDA records is "The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0120-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Lifeline First Aid LLC
Product
ARC 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.
Product code
LRR First Aid Kit With Drug
Reason for recall
The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad.
Root cause tag
manufacturing process
FDA root cause
Material/Component Contamination
Action
Lifeline 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 commerce
320 kits
Distribution
Nationwide Distribution
Product codes and lots
no codes.