BEUDAMED
    FDA Recall 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 · Initiated February 7, 2014

    Recall

    Recall Number
    Z-0991-2014
    Event Number
    67492
    Firm
    Biocardia, Inc.
    FEI Number
    3003610571
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 7, 2014
    Posted
    February 19, 2014
    Terminated
    April 3, 2014
    Address
    125 Shoreway Rd, Ste B, San Carlos, CA, 94070-2718

    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.

    Action

    Sales Representative called each affected hospital on February 7, 2014, to notify them of the recall. BioCardia has initiated a recall of Morph AccessPro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Sales representatives contacted hospital sites identified in Attachment 3 by telephone. Script provided as follows: "BioCardia has initiated a recall of Morph Access Pro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Our records indicate that we sold you. The recall is limited to these units in this lot sold to you. We would like to confirm if you still have the unit(s). If you do, we ask that you quarantine the unit(s) and our customer service department will contact you to coordinate the return of the unit(s)." For further questions please call (650) 226-0133.

    Distribution

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

    Quantity

    11 units