Z-1088-2013 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2013
- Initiation Date
- March 22, 2013
- Termination Date
- November 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,133 kits
Product Description
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
Reason for Recall
The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
Distribution Pattern
Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.
Code Information
All kits shipped between 1/12010 through 3/4/2013.