Z-1090-2013 Class III Terminated

Recalled by Lighthouse For The Blind — Olivette, MO

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
41,595 kits

Product Description

LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. 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.