Cook Inc.: CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

Is my product affected?

CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

• UPC 00827002515772

Check against the official notice below — it lists the full affected range.

What happened

Cook Inc. is recalling certain CrossCath Support Catheters due to a manufacturing error affecting the radiopaque marker bands. On CXC3.0 models (compatible with 0.014 wire guides), the marker bands may be too loose, while on CXC3.4 models (compatible with 0.018 wire guides), they may be too tight. These catheters are used for diagnostic and interventional vascular procedures. A total of 58 units were distributed across multiple U.S. states (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 affected devices are identified by lot numbers 9950878 and 9953506. The recall record does not specify a remedy or recommended action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A manufacturing error 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).

Details from the source

Reason for recall: A manufacturing error 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). Distribution: Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil. Quantity: 58 Lot/code info: Lot Numbers 9950878, 9953506 UDI: (01)00827002515772(17)221508(10)9950878 UDI: (01)00827002515772(17)221608(10)9953506

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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