medical Class I Updated 2019-12-18

Cook Inc. recalls CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Or

Recalled Product

CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.

Hazard / Issue

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).

Issued by

FDA

Affected States: AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA
Lot/Code Info: Lot Numbers 9945301, 9953512 UDI: (01)00827002515833(17)221308(10)9945301 UDI: (01)00827002515833(17)221608(10)9953512
View official government recall

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