BEUDAMED
    FDA Enforcement Class II Terminated

    MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.

    Recall: Z-0991-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-0991-2014
    Event ID
    67492
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biocardia, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 26, 2014
    Initiation Date
    February 7, 2014
    Classification Date
    February 19, 2014
    Termination Date
    April 3, 2014
    Address
    125 Shoreway Rd Ste B, San Carlos, CA, 94070-2718, United States

    Description

    MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.

    Reason

    Tyvek packaging may be worn, causing loss of package integrity.

    Code Info

    Catalog number MAP690; Lot numbers 01162 and 01186.

    Distribution

    US Distribution including the states of FL, MA, WY. OH, MI and KS.

    Quantity

    11 units