BEUDAMED
    FDA Recall Terminated

    Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).

    Recall: Z-1546-2018 · Initiated March 28, 2018

    Recall

    Recall Number
    Z-1546-2018
    Event Number
    79702
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    GCX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 28, 2018
    Terminated
    November 29, 2018
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).

    Reason

    products may be missing a one-way valve on the fluid patient port.

    Action

    Cardinal Health sent an Urgent Product Recall letter dated March 28, 2018, Please take the following actions: 1. INSPECT your inventory for the affected product code and lot number (listed on package) 2. SEGREGATE and QUARANTINE all on-hand product 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined 4. CONTACT Customer Service at 800-964-5227 to arrange for return and credit of any affected product . For further questions, please call (800) 292- 9332.

    Distribution

    US Distribution to the state of MA

    Quantity

    3600 units