BEUDAMED
    FDA Recall Terminated

    AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

    Recall: Z-0947-2019 · Initiated October 2, 2018

    Recall

    Recall Number
    Z-0947-2019
    Event Number
    81375
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 2, 2018
    Terminated
    November 12, 2021
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

    Reason

    Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.

    Action

    On October 2, 2018, the firm notified consignees via an Urgent Medical Device Recall letter. The letter informed customers of the product issue. Customers were instructed to take the following actions: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have any other questions, feel free to contact your local sales representative or Teleflex Customer Service at 1-866-396-2111.

    Distribution

    Nationwide distribution.

    Quantity

    5