Lighthouse For The Blind Recalls First Aid Kits With Misleading Sterility Labels
Lighthouse For The Blind is recalling 425 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a labeling error regarding sterility claims, with no reported injuries or illnesses.
Plain-English summary
Lighthouse For The Blind is recalling 425 units of the LHB, Perishable Items Pack Type IV First Aid Kit (Kit number: 2114016-100). The recall involves kits shipped between January 12, 2010, and March 4, 2013. The kits 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.
The recall is due to a labeling error on the iodine 10% Ampule (10% Povidone Iodine swab) included in the kit. 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 mislabeling could lead users to believe the solution is sterile when it is not.
Consumers who have this specific first aid kit should stop using the iodine ampules and contact Lighthouse For The Blind for further instructions or a replacement. The recall is being conducted in coordination with the firm's distributor.
The recalled product
- Product
- LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
- Manufacturer
- Lighthouse For The Blind
- Category
- Medical Device — First Aid Kit
- Hazard
- Affected units
- 425
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
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 →Related recalls
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- LowLighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error
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