Cook Medical CXI Support Catheters Recalled Due to Product Mixing
Cook Inc. is recalling specific lots of CXI Support Catheters because the 2.6FR curved and 4.0FR straight catheters were mixed during processing.
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. The hazard involves product mixing during processing, which is a quality control issue. No injuries or illnesses are reported in the source text, and the risk is theoretical rather than confirmed harm, fitting the criteria for a moderate severity score.
Plain-English summary
Cook Inc. is recalling 38 units of Cook Medical CXI Support Catheters, specifically the 2.6FR curved catheter and the 4.0FR straight catheter, intended for cardiovascular use. The recall affects specific catalog numbers and lots with an expiration date of December 10, 2017.
The recall was initiated after Cook Medical received six product complaints indicating that the 2.6FR curved catheter was mixed with the 4.0FR straight catheter, and vice versa. An investigation determined that the products were mixed during the processing stage.
The affected products were distributed worldwide, including in the United States (CA, FL, ID, IL, MA, NY, OK, TX, UT, and VA) and in Canada, Austria, Germany, Spain, France, Hungary, Sweden, and the UK. Users should stop using the affected lots and contact Cook Inc. for further instructions.
The recalled product
- Product
- Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
- Manufacturer
- Cook Inc.
- Affected units
- 38
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)
- 2017
Distribution
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