BEUDAMED
    FDA Enforcement Class II Terminated

    PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

    Recall: Z-0716-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0716-2021
    Event ID
    86797
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Prytime Medical Devices, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    October 29, 2020
    Classification Date
    December 23, 2020
    Termination Date
    January 11, 2023
    Address
    229 N Main St, N/A, Boerne, TX, 78006-2035, United States

    Description

    PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

    Reason

    There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.

    Code Info

    Lot # 205936

    Distribution

    US Nationwide distribution in the state of Utah.

    Quantity

    3 units