The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-1091-2013·Announced 2013-04-17

Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling

Lighthouse For The Blind is recalling 227 First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Lighthouse For The Blind is recalling 227 units of the LHB Perishable Item Pack Type III First Aid Kit (Kit number: 2114011-100). The recall was initiated because the labeling on the iodine 10% Ampule (10% Povidone Iodine swab) contained within the kits states that the contents of the package are sterile. This labeling does not clarify that the sterility claim applies only to the applicator, not the antiseptic solution, which is a cutaneous disinfectant.

The affected kits were shipped between January 12, 2010, and March 4, 2013. The products were distributed nationwide, including the District of Columbia 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.

Consumers who possess these kits should stop using the iodine ampules and contact the recalling firm for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
Manufacturer
Lighthouse For The Blind
Category
Medical Device — First Aid Kit
Hazard
Affected units
227

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All kits shipped between 1/12010 through 3/4/2013.

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Lighthouse For The Blind under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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