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Recall Observatory FDA recall evidence

Device product

LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.

Z-1089-2013

March 22, 2013

Class III

Product summary

Firm
Lighthouse For The Blind
Event
Event 64776
Status
Terminated
Classification
Class III
Quantity
1,034 kits
Official record key
device-enforcement:Z-1089-2013

Official wording

Reason: 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

Code information: All kits shipped between 1/12010 through 3/4/2013.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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