Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error
Lighthouse For The Blind is recalling First Aid Type IV Belt Type kits because the iodine ampule labels incorrectly imply the entire package 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 unlikely to cause adverse health consequences. The issue is a labeling error regarding sterility claims, which falls under the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Lighthouse For The Blind is recalling 6,075 units of First Aid Type IV Belt Type kits (NSN #6545-01-010-7754, Kit number: 114016). 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) 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 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 specific kits should stop using them and contact Lighthouse For The Blind for further instructions.
The recalled product
- Product
- LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
- Manufacturer
- Lighthouse For The Blind
- Category
- Medical Device — First Aid Kits
- Hazard
- Affected units
- 6,075
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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FDA (Devices) · 2013-04-17
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- LowLighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error
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