Lighthouse For The Blind Recalls Antiseptic Kits Due to Sterility Labeling Error
Lighthouse For The Blind is recalling 2,815 antiseptic kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.
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 as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a labeling error regarding sterility claims, not a contamination or functional defect.
Plain-English summary
Lighthouse For The Blind is recalling 2,815 units of its Antiseptic Kit, Kit Number 2113305. The kits contain a Povidone Swab, Gauze Pads, and non-stick pads. The recall is being initiated because the labeling on the iodine 10% Ampule (10% Povidone Iodine swab) states that the contents of the package are sterile. This labeling does not clarify that the sterility claim is only applicable to the applicator, not the antiseptic solution itself.
The antiseptic solution applied to the skin is a cutaneous disinfectant and is not sterile. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The 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.
All affected kits were shipped between 1/12/2010 and 3/4/2013. Consumers who have these kits should stop using them and contact Lighthouse For The Blind for further instructions.
The recalled product
- Product
- LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
- Manufacturer
- Lighthouse For The Blind
- Hazard
- Affected units
- 2,815
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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