The Recall Desk
LowFDA (Devices)·Z-1088-2013·Announced 2013-04-17

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

Lighthouse For The Blind is recalling 56,133 First Aid Type I Individual Kits because the iodine ampule labels incorrectly imply 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding sterility claims.

Plain-English summary

Lighthouse For The Blind is recalling 56,133 First Aid Type I Individual Kits (NSN: 6545-00-656-1092, Kit number: 2114002). The recall involves kits shipped between January 12, 2010, and March 4, 2013. These kits were distributed nationwide, including the District of Columbia and 33 states.

The recall is due to a labeling error on the iodine 10% Ampule (10% Povidone Iodine swab) contained in the kits. The labels state that the contents of the package are sterile, but they do not clarify that this sterility claim applies only to the applicator. The antiseptic solution itself is a cutaneous disinfectant and is not sterile. This labeling issue is being addressed in coordination with the firm's distributor.

Consumers who have these kits should stop using the iodine ampules and contact Lighthouse For The Blind for further instructions or a replacement. The recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.

The recalled product

Product
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
Affected units
56,133

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 →