BEUDAMED
    FDA Recall Terminated

    Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.

    Recall: Z-1666-2011 · Initiated February 23, 2011

    Recall

    Recall Number
    Z-1666-2011
    Event Number
    58053
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 23, 2011
    Posted
    March 16, 2011
    Terminated
    September 13, 2012
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.

    Reason

    Tubing connectors incorrectly packaged and labeled.

    Action

    The firm, Maquet, sent a "PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION" letter dated February 22, 2011 via Federal Express to its customer. The letter described the product, problem and the action to be taken. The customer was instructed to examine their inventory immediately to identify and remove the affected connectors and complete and return the attached RECALL- Device Corrective Action Response Form via fax to Director of Regulatory Affairs at (973) 709-7016 or email: [email protected]. If you have any additional questions, please contact your local MAQUET Cardiovascular Sales Representative or customer service at 1-800-777-4222.

    Distribution

    Nationwide distribution: USA state of CA.

    Quantity

    40 BEQ-HG 0284 3/8" x 3/8" Lot 70041098 Connectors