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04-18-2013, 02:12 PM #1
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- Aug 2012
- Merced, CA 95348-1422
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Recall :LHB ( Lighthouse for the Blind) First Aid Kits
LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
Recall Number Z-1086-2013
Classification Class III
Code Info All kits shipped between 1/12010 through 3/4/2013.
Product Distributed Qty 635 kits
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 sterilized.
Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile.
It was determined that labeling on certain products could be misleading in relation to sterility claims.
Event Id 64776
Product Type Devices
Recalling Firm Lighthouse For The Blind, Olivette, MO, USA
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-22
Initial Firm Notification of Consignee or Public E-Mail
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.
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