BEUDAMED
    FDA Recall Terminated

    Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01

    Recall: Z-1642-2019 · Initiated April 18, 2019

    Recall

    Recall Number
    Z-1642-2019
    Event Number
    82703
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 18, 2019
    Posted
    May 31, 2019
    Terminated
    July 28, 2025
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01

    Reason

    Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

    Action

    Maquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 1 888 627 8383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time. On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQ TOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051.

    Distribution

    Nationwide