Cook CrossCath Support Catheter Recall Due to Manufacturing Error
Cook Inc. is recalling 20 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a severity score of at least 4 per the rubric.
Plain-English summary
Cook Inc. is recalling 20 units of the CrossCath Support Catheter, model RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572, Lot Number 9945302. 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 agency has classified this as a Class I recall.
The affected products were distributed to the US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, as well as Brazil. Users should stop using the affected devices and contact Cook Inc. for instructions.
The recalled product
- Product
- CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
- Manufacturer
- Cook Inc.
- Affected units
- 20
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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