BEUDAMED
    FDA Recall Terminated

    OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G X 1 Y." (1) NEEDLE HYPODERMIC 25G X 5/8" (2) EYE PAD 2 1/8 X 2 5/8 UF (5) EYE SPEAR MICRO SPONGE (2) LITE GLOVE LIF (1) CABLE BIPOLAR (1) EYE SHIELD UNIVERSAL (1) OPHTALMIC PENCIL BIPOLAR (1) IV ADM. SET 15 DROPS 106" LONG L/F (1) TABLE COVER REINFORCED 50" X 90" UF (1) KNIFE/BLADE MIN. EDGE ROUND (1) KNIFE 15 5.0 CONTROLLED (1) PLASTIC TRAY 3/COMPARTMENT (1)KNIFE 3.2MM ANGLE BEVEL UP (1) CYSTOTOMO IRRIG. 25GA X5/8 (1) MAYO TRAY LARGE (2) GOWN STANDARD LARGE SMS STD VELCRO NECK (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    Recall: Z-2318-2014 · Initiated May 20, 2014

    Recall

    Recall Number
    Z-2318-2014
    Event Number
    68536
    Firm
    Customed, Inc Calle Igualdad Final # 7
    FEI Number
    2648727
    Product Code
    OJK
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 20, 2014
    Posted
    August 29, 2014
    Terminated
    August 14, 2017
    Address
    Fajardo, PR, 00738

    Description

    OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G X 1 Y." (1) NEEDLE HYPODERMIC 25G X 5/8" (2) EYE PAD 2 1/8 X 2 5/8 UF (5) EYE SPEAR MICRO SPONGE (2) LITE GLOVE LIF (1) CABLE BIPOLAR (1) EYE SHIELD UNIVERSAL (1) OPHTALMIC PENCIL BIPOLAR (1) IV ADM. SET 15 DROPS 106" LONG L/F (1) TABLE COVER REINFORCED 50" X 90" UF (1) KNIFE/BLADE MIN. EDGE ROUND (1) KNIFE 15 5.0 CONTROLLED (1) PLASTIC TRAY 3/COMPARTMENT (1)KNIFE 3.2MM ANGLE BEVEL UP (1) CYSTOTOMO IRRIG. 25GA X5/8 (1) MAYO TRAY LARGE (2) GOWN STANDARD LARGE SMS STD VELCRO NECK (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF 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.

    Action

    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

    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

    2 lots; 60 units (multiple units per lot)