BEUDAMED
    FDA Enforcement Class II 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 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0097-2015
    Event ID
    69319
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    August 22, 2014
    Classification Date
    October 20, 2014
    Termination Date
    April 15, 2015
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    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.

    Code Info

    1) DeRoyal(R), REF 71-6510, Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622

    Distribution

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

    Quantity

    13,900 units