BEUDAMED
    FDA Recall Terminated

    Bio Med Devices Disposable Pediatric Breathing Circuit, One Set Catalog Number: 4040LC 5 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilators

    Recall: Z-0972-2011 · Initiated October 19, 2010

    Recall

    Recall Number
    Z-0972-2011
    Event Number
    57051
    Firm
    Biomed Devices
    FEI Number
    3003952420
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    October 19, 2010
    Posted
    January 27, 2011
    Terminated
    October 23, 2014
    Address
    61 Soundview Rd, Guilford, CT, 06437-2937

    Description

    Bio Med Devices Disposable Pediatric Breathing Circuit, One Set Catalog Number: 4040LC 5 foot /15mm corrugated EVA hose Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilators

    Reason

    Breathing circuit may disconnect between the adapter adjacent tubing cuff

    Action

    The firm,Bio Med Devices, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 18, 2010 via fax to the customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to immediately examine their stock for the affected lots, if found, discontinue distributing and using the product and promptly return via UPS #025106 to Bio-Med Devices 61 Soundview Rd, Guilford, CT 06437, Attention: 4040LC Recall Return. The customers were also instructed to immediately contact their accounts, if the product was further distributed , advise them of the recall situation and have their outstanding product returned, and to complete and return the RETURN FAX-IMMEDIATE RESPONSE REQUIRED form via fax to 203-458-0440. Note: Bio-Med informed the customers that they will credit the return product; however, they only plan to replace the product in an emergency situation, because they have very few of the 3/8" x 15mm adapters left and are looking to discontinue the 4040LC due to the discontinuance of this product by the manufacturer. If you have any questions, please contact (203) 458-0202 x 217.

    Distribution

    Nationwide distribution: OH, WI.

    Quantity

    15 cases (20/cs)