BEUDAMED
    FDA Recall Terminated

    Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005

    Recall: Z-0935-2020 · Initiated November 20, 2019

    Recall

    Recall Number
    Z-0935-2020
    Event Number
    84365
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 20, 2019
    Terminated
    October 16, 2020
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005

    Reason

    Potential for leakage at the joint between the blood filters and tubing

    Action

    On 11/20/2019, B Braun Medical Inc. issued Urgent Medical Device letters and Product Removal Acknowledgment forms to customers. On 11/20/2019, B Braun Medical Inc. also issued a press release. 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 mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward a copy of the recall notification to your customers. 2. Determine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the 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 PA_QualityAssurance. 5. If you have any full cases, partial cases or unused individual pieces of these affected products as identified in the Product Removal Acknowledgement form that was submitted to BBMI Quality Assurance Department, a BBMI 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 Clinical and Technical Support Department at 1-800-854-6851.

    Distribution

    US Nationwide

    Quantity

    1,824 units