BEUDAMED
    FDA Enforcement Class II Terminated

    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.

    Recall: Z-1400-2015 · Reported April 15, 2015

    Enforcement

    Recall Number
    Z-1400-2015
    Event ID
    70719
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Civco Medical Instruments Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 15, 2015
    Initiation Date
    February 26, 2015
    Classification Date
    April 8, 2015
    Termination Date
    February 28, 2017
    Address
    102 1st St S, N/A, Kalona, IA, 52247-9589, United States

    Description

    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.

    Reason

    Leaks were detected in the recalled lot which may compromise the sterility of the product.

    Code Info

    Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01

    Distribution

    Distributed to the states of CA, IL, MA, MI, MO, and WI.

    Quantity

    120 pouches