Cook Inc.: CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.

Is my product affected?

CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.

• UPC 00827002515727

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

What happened

Cook Inc. is recalling 20 CrossCath Support Catheters due to a manufacturing error affecting the radiopaque marker bands. The CXC3.0 model catheters (compatible with 0.014 wire guides) may have marker bands that are too loose, while the CXC3.4 model catheters (compatible with 0.018 wire guides) may have marker bands that are too tight. The affected catheters are identified by Lot Number 9945302 and were distributed to medical facilities in Alabama, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Brazil.

These catheters are used for diagnostic and interventional vascular procedures. The source document does not specify a remedy or corrective action for affected consumers or healthcare providers.

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: 20 Lot/code info: Lot Number 9945302 UDI: (01)00827002515727(17)221308(10)9945302 edited to add 2/25/20.

Source

Official record: FDA (Device enforcement) ↗

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

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