Applied Medical Recalls Biliary Catheters Due to Packaging Particulate Matter
Applied Medical is recalling specific lots of biliary catheters because packaging particulate matter may reside on the product.
What this means for you
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, and the hazard involves potential packaging particulate matter without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Applied Medical Resources Corp is recalling specific lot numbers of its biliary catheters, including models A4752, A4754, A4762, CB052308, CB054008, and CB062313. The recall involves 40,238 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the catheters may have a potential for packaging particulate matter to reside on the product. These devices are indicated for the removal of stones and ductal debris from the biliary system.
Healthcare facilities and distributors should stop using the affected units and contact Applied Medical Resources Corp for further instructions on the recall.
The recalled product
- Product
- Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH
- Manufacturer
- Applied Medical Resources Corp
- Affected units
- 40,238
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 (2)
- Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852
- 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Applied Medical Resources Corp 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.
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