BEUDAMED
    FDA Recall Terminated

    Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer Blood Collection or Urine Collection Tubes.

    Recall: Z-2393-2021 · Initiated August 2, 2021

    Recall

    Recall Number
    Z-2393-2021
    Event Number
    88338
    Firm
    Magnolia Medical Technologies, Inc.
    FEI Number
    3009976527
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 2, 2021
    Terminated
    February 22, 2023
    Address
    200 W Mercer St, Ste 500, Seattle, WA, 98119-5908

    Description

    Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer Blood Collection or Urine Collection Tubes.

    Reason

    Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).

    Action

    On or about 08/02/2021, the firm hand delivered via its Clinical Team an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customers informing them that a specific lot number of transfer adapters was shipped with the incorrect Instructions for Use. Customers are instructed to work with the Recalling Firm's Clinical Team member in identifying the affected products so that replacement Instructions for Use can be provided at no cost. Customers are also instructed to complete a Customer Acknowledgement Form, to record the quantity of affected products each customer has in their inventory and return to their local Recalling Firm's Clinical Team member, or directly to the Recalling Firm. For questions or assistance, contact Customer Service and Sales at 415-969-8183 or email [email protected]

    Distribution

    U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A

    Quantity

    9,400 units