Cook Inc. Recalls CrossCath Support Catheters Due to Manufacturing Error
Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.
What this means for you
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 I recall, which indicates a reasonable probability that the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls must be scored at least 4 (Severe). However, the source text does not report any injuries, illnesses, or deaths, and describes a manufacturing defect regarding marker band tightness rather than a known fatality scenario. Given the strict rule that Class I never goes below 4, but also considering the lack of reported harm, this sits at the lower bound of severe risk defined by the agency's classification.
Plain-English summary
Cook Inc. is voluntarily recalling certain CXC3.0 and CXC3.4 CrossCath Support Catheters. The recall affects Order Number G51583, which includes 43 units distributed to the United States (specifically Alabama, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia) and Brazil.
The recall was initiated because a manufacturing error may cause the radiopaque marker bands on these catheters to be too loose on CXC3.0 models (compatible with 0.014 wire guides) or too tight on CXC3.4 models (compatible with 0.018 wire guides). The affected lot numbers are 9945301 and 9953512.
Consumers who possess these specific catheters should stop using them and contact Cook Inc. for further instructions.
The recalled product
- Product
- CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
- Manufacturer
- Cook Inc.
- Affected units
- 43
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)
- Lot Numbers 9945301
Distribution
Part of a larger recall action
This product is one of 4 recalled by Cook Inc. 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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