FDA-Device2013-04-17Class III
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
Lighthouse For The Blind
Hazard
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
Sold states
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.
Affected count
425 kits
Manufactured in
10440 Trenton Ave, Olivette, MO, United States
Products
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1093-2013Don't want to check this manually?
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