BEUDAMED
    FDA Recall Terminated

    Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital

    Recall: Z-0097-2015 · Initiated August 22, 2014

    Recall

    Recall Number
    Z-0097-2015
    Event Number
    69319
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    KDQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 22, 2014
    Posted
    October 20, 2014
    Terminated
    April 15, 2015
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital

    Reason

    These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.

    Action

    DeRoyal sent an Urgent Voluntary Recall letter dated August 22, 2014, to all affected consignees by overnight letter or by email. DeRoyal was to follow up with non-responding accounts before October 1, 2014. Customers were instructed to check their inventory for the affected product. If they have affected product, customers were instructed to destory both the liner and the lid and dispose of it according to their facility's procedures. Customers were instructed to return the included Notice of Destruction to [email protected] even if they no longer have affected product. Customers with questions were instructed to contact their DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864. For questions regarding this recall call 865-362-2334.

    Distribution

    Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY

    Quantity

    13,900 units