BEUDAMED
    FDA Recall Terminated

    The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

    Recall: Z-0318-2022 · Initiated November 2, 2021

    Recall

    Recall Number
    Z-0318-2022
    Event Number
    88919
    Firm
    Magnolia Medical Technologies, Inc.
    FEI Number
    3009976527
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 2, 2021
    Terminated
    May 8, 2023
    Address
    200 W Mercer St, Ste 500, Seattle, WA, 98119-5908

    Description

    The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

    Reason

    Due to an uptick of complaints associated with premature needle retraction of blood collection system.

    Action

    On 11/02/2021, the Recalling Firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter to customers via email informing them that the firm has received a number of product complaints associated with its blood collecting systems where the retractable feature of the butterfly needles may prematurely activate. The product complaints have been associated with retractable feature being activated within the product packaging. Customers are instructed to: -Determine the quantity of the affected products remaining at their facility and communicated this to the Recalling Firm's Sales or Clinical team members. -The Recalling Firm will replace any of the affected products at no cost to the customer. -Notify all their staff of the recall and if the affected products have been further distributed, to contact/notify those customers/organization of this recall.

    Distribution

    U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.

    Quantity

    137,200 devices