BEUDAMED
    FDA Recall Terminated

    Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

    Recall: Z-2346-2015 · Initiated June 19, 2015

    Recall

    Recall Number
    Z-2346-2015
    Event Number
    71510
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    GBZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 19, 2015
    Posted
    August 5, 2015
    Terminated
    March 21, 2016
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

    Reason

    Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter

    Action

    Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).

    Distribution

    AZ, CA, LA. IN, NC, TN, TX, VA

    Quantity

    62 cases (10/cs)=620 units