Cook Inc. Recalls Dawson-Mueller Drainage Catheters Due to Leakage Risk
Cook Inc. is recalling specific lots of Dawson-Mueller Drainage Catheters because they were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall for a medical device with a manufacturing defect that could lead to leakage. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling specific lots of Dawson-Mueller Drainage Catheters, including the Multipurpose Drainage Catheter models RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6.3-35-25-P-58-CLDM-HC, and UL T7.0-35-25-P-5S-CLDM-HC. The recall involves 1,604 units that were distributed domestically across the United States and internationally to Australia, Belgium, Canada, China, Colombia, Denmark, France, Germany, Italy, Korea, Netherlands, New Zealand, Peru, Russia, Spain, Sweden, and the United Kingdom.
The recall was initiated because the specific lots were not manufactured to specification. This manufacturing defect could lead to leakage from the Mac-Loc hub assembly. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should identify and stop using the affected lots immediately. Consumers and patients should contact their healthcare provider if they have been using these specific catheters to discuss the potential risk of leakage and appropriate next steps.
The recalled product
- Product
- Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC
- Manufacturer
- Cook Inc.
- Affected units
- 1,604
Distribution
Distributed nationwide across the United States.
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