Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error
Lighthouse For The Blind is recalling 41,595 First Aid Type III kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.
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 by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding sterility claims, fitting the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Lighthouse For The Blind is recalling 41,595 First Aid Type III kits (NSN # 6545-00-656-1094, Kit number: 2114011) due to a labeling error on the included iodine 10% ampules. The kits were distributed nationwide, including DC and 35 states, between January 12, 2010, and March 4, 2013.
The recall was initiated because the labels on the iodine 10% ampules state that the contents of the package are sterile. However, the labeling does 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 possess these kits should stop using the iodine ampules and contact the distributor or Lighthouse For The Blind for further instructions. 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 III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
- Manufacturer
- Lighthouse For The Blind
- Category
- Medical Device — First Aid Kits
- Hazard
- Affected units
- 41,595
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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