MAHURKAR and Argyle acute hemodialysis catheters recalled for inaccurate priming volume labels
COVIDIEN LLC is recalling MAHURKAR and Argyle acute hemodialysis catheters because the printed priming volume values are higher than the volumes required to fill each lumen.
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, and the hazard is a labeling error (inaccurate priming volume values) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
COVIDIEN LLC is recalling MAHURKAR and Argyle acute hemodialysis catheters. The recall involves 2,223,067 units distributed nationwide in the United States, as well as to Canada, Australia, New Zealand, Latin America, and Hong Kong. The affected products include various material numbers listed in the recall notice.
The reason for the recall is that the priming volume values printed on the catheters and their Instructions for Use (IFU) are higher than the actual volumes required to fill each lumen. This labeling discrepancy could potentially affect the accuracy of the priming process during hemodialysis procedures.
Healthcare facilities and consumers who have these specific catheters should stop using them and contact COVIDIEN LLC for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007…
- Manufacturer
- COVIDIEN LLC
- Hazard
- Affected units
- 2,223,067
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 lots
Distribution
Distributed nationwide across the United States.
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