FDAFDA · Food and drugs·Recall number Z-1091-2013
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
Published April 17, 2013 · Recall initiated: March 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Lighthouse For The Blind
- Distributor
- 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.
- Lot
- All kits shipped between 1/12010 through 3/4/2013.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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