BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-0589-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0589-2020
    Event ID
    84212
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2019
    Initiation Date
    November 8, 2019
    Classification Date
    December 9, 2019
    Termination Date
    February 1, 2021
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

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

    Reason

    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).

    Code Info

    Lot Numbers 9945301, 9953512 UDI: (01)00827002515833(17)221308(10)9945301 UDI: (01)00827002515833(17)221608(10)9953512

    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