The Recall Desk
LowFDA (Devices)·Z-1086-2013·Announced 2013-04-17

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

Lighthouse For The Blind is recalling 635 Type I First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.

What this means for you

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

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a labeling error regarding sterility claims rather than a contamination or functional defect.

Plain-English summary

Lighthouse For The Blind is recalling 635 Type I First Aid Kits (Kit Number: 2113110) due to a labeling error on the included iodine 10% Ampule. The kits were distributed nationwide, including DC and 34 states, between January 12, 2010, and March 4, 2013.

The recall was initiated because the labeling on the iodine 10% Ampule states that the contents of the package are sterile. This claim does not clarify that the sterility applies only to the applicator, not the antiseptic solution. The solution is a cutaneous disinfectant and is not sterile.

Consumers who possess these kits should stop using the iodine ampules and contact Lighthouse For The Blind for instructions on how to return the product.

The recalled product

Product
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.
Affected units
635

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 →