Cook Inc. Recalls CrossCath Support Catheters Due to Marker Band Fit Issues
Cook Inc. is recalling 58 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is by definition unlikely to cause adverse health consequences. The source text does not report any injuries or illnesses, and the defect is a manufacturing fit issue rather than a direct safety hazard like a fracture or contamination.
Plain-English summary
Cook Inc. is recalling 58 units of the CrossCath Support Catheter, model RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577. The recall involves Lot Numbers 9950878 and 9953506. These devices are used for diagnostic and interventional vascular procedures.
The recall is due to a manufacturing error that may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides). The source text does not report any illnesses, injuries, or deaths associated with this defect.
The affected devices were distributed to the following US states: AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, as well as to Brazil. Healthcare providers should stop using the affected devices and contact Cook Inc. for further instructions.
The recalled product
- Product
- CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 58
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 9950878
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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