BEUDAMED
    FDA Recall Terminated

    Infusomat Space Volumetric Pump Administration Set, Product Code 490100

    Recall: Z-2137-2021 · Initiated June 25, 2021

    Recall

    Recall Number
    Z-2137-2021
    Event Number
    88198
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 25, 2021
    Terminated
    October 16, 2023
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Infusomat Space Volumetric Pump Administration Set, Product Code 490100

    Reason

    There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

    Action

    Urgent Medical Device Recall Notification letters dated 6/25/21 were sent to customers. Actions Required By BBMI Customer/User: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the customer level. 2. Determine your current inventory of the affected lot within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Product Removal Acknowledgement," form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Product Removal Acknowledgement" form to B. Braun Medical Inc. Quality Assurance department by faxing the form to ( 610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. If you have any full cases, partial cases or unused individual pieces of this affected product as identified in the "Product Removal Acknowledgement" form that was submitted to BBMI Quality Assurance Department, a BBMl Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. Should you identify product where this issue has occurred, please report the event promptly to BBMI by contacting our Medical Affairs Department at 1-800-854-6851.

    Distribution

    Affected products were distributed to the following US states: CA, MI, OR, and UT.

    Quantity

    36,144 units