ASO Recalls Carepak Bandages Due to Unlabeled Benzalkonium Chloride
ASO, LLC is recalling Carepak Sheer Adhesive Bandages because 5/8 bandages contain 0.1% Benzalkonium Chloride, which is not listed on the label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error (unlisted ingredient) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
ASO, LLC is recalling 655 cases of Carepak Sheer Adhesive Bandages, 50 Sterile Bandages Assorted Sizes. The recall involves Model #141168, Lots #s 00013359, 00020722, and 00028721. The product was distributed in Rhode Island.
The recall was initiated because the 5/8 bandages within the assortment contain 0.1% Benzalkonium Chloride. This ingredient is not listed as an active ingredient on the product label.
Consumers who have purchased these specific bandages should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
- Manufacturer
- ASO, LLC
- Affected units
- 655
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 (3)
- Model #141168
- Lots #s 00013359
- 00020722 and 00028721.
Distribution
Distributed in 1 state:
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