Alcon Custom Pak recalled due to supplier x-ray detectable sponge issue
Alcon Research is recalling Alcon Custom Paks because a supplier recalled x-ray detectable sponges used in the product.
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 does not report any illnesses, injuries, or specific hazards, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Alcon Research, LTD. is initiating a medical device recall for Alcon Custom Paks. The recall was initiated after Alcon received a notification from a supplier regarding a recall of x-ray detectable sponges.
The supplier recall notification references one specific product that is used within Alcon Custom Paks. The source text does not specify the exact nature of the defect in the sponges or the specific risks associated with the supplier's recall.
The recall affects 33 units of Alcon Custom Paks with codes 2033459H, 2034186H, and 2034491H. These units were distributed in Wisconsin, New York, and Missouri. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Alcon Custom Pak
- Manufacturer
- Alcon Research, LTD.
- Hazard
- Affected units
- 33
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)
- 2033459H
- 2034186H
- 2034491H
Distribution
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