Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error
Lighthouse For The Blind is recalling 1,034 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 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 1,034 First Aid Kits (Kit Number: 2114002-100) due to a labeling error on the included iodine 10% Ampule. The labels state that the contents of the package are sterile, but they fail to clarify that this sterility claim applies only to the applicator, not the antiseptic solution.
The antiseptic solution is a cutaneous disinfectant and is not sterile. The recall covers kits shipped between January 12, 2010, and March 4, 2013. These kits were distributed nationwide, 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.
Consumers should stop using the affected kits and contact Lighthouse For The Blind for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
- Manufacturer
- Lighthouse For The Blind
- Category
- Medical Device — First Aid Kit
- Hazard
- Affected units
- 1,034
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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