CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
Check against the official notice below — it lists the full affected range.
Cook Inc. has recalled CrossCath Support Catheters, model RPN CXC3.4-2.2-18-135-P-NS-0, due to a manufacturing error affecting the radiopaque marker bands. The marker bands may be too loose on certain CXC3.0 models (compatible with 0.014 wire guides) and too tight on certain CXC3.4 models (compatible with 0.018 wire guides). A total of 43 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) as well as Brazil. The affected lot numbers are 9945301 and 9953512.
The source document does not specify any remedy or corrective action for consumers to take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
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: 43 Lot/code info: Lot Numbers 9945301, 9953512 UDI: (01)00827002515833(17)221308(10)9945301 UDI: (01)00827002515833(17)221608(10)9953512
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.