BEUDAMED
    FDA Enforcement Class I Terminated

    UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4" X 4" 12 PLY (1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS (3) TOWELS ABSORBENT 15" X 20" LIF (1) TUR Y SET 81"2.1m REGULAR CLAM ST. (1) TUBE SUCTION CONNECT Y4" X 12' LIF (1) BAG SUTURE FLORAL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    Recall: Z-2355-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2355-2014
    Event ID
    68536
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Customed, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    May 20, 2014
    Classification Date
    August 29, 2014
    Termination Date
    August 14, 2017
    Address
    Calle Igualdad Final #7, Fajardo, PR, 00738, United States

    Description

    UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4" X 4" 12 PLY (1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS (3) TOWELS ABSORBENT 15" X 20" LIF (1) TUR Y SET 81"2.1m REGULAR CLAM ST. (1) TUBE SUCTION CONNECT Y4" X 12' LIF (1) BAG SUTURE FLORAL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    Reason

    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

    Code Info

    Product code 900-868, 36 lots: 111030667 111040921 111051390 111061692 111071970 111082114 111092560 111102783 111123143 111123300 112010206 112020509 112030750 112041359 112052020 112083060 112093955 112114402 112114485 112114583 112125119 113015518 113015570 113036769 113057511 113078350 113088896 113099297 113109649 113109878 131210844 140111254 140211858 140412476 140412909 140513484

    Distribution

    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

    Quantity

    36 lots; 1900 units (multiple units per lot)