BEUDAMED
    FDA Recall Terminated

    CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

    Recall: Z-1822-2020 · Initiated March 16, 2020

    Recall

    Recall Number
    Z-1822-2020
    Event Number
    85260
    Firm
    Avanos Medical, Inc.
    FEI Number
    3011270181
    Product Code
    PSG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 16, 2020
    Terminated
    August 31, 2023
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

    Reason

    The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.

    Action

    On March 16, 2020 Avanos Medical (formerly Halyard Health) sent out an URGENT Product Recall Notice via letter identifying the problem and under what circumstances it can occur. PRODUCTS: This Recall applies to the previously mentioned CORFLO* PEG Kits that were manufactured after April 8, 2019 and can be identified by the product code and lot number found on the CORFLO* PEG Kit label. ACTION TO BE TAKEN BY CUSTOMER: CHECK all storage and usage locations to determine if any impacted product remains within your possession for any Unsold Inventory SEGREGATE and QUARANTINE the devices according to your facility 's procedures, then IMMEDIATELY COMPLETE and RETURN the attached Recall Acknowledgement Form to Avanos. If consignee is located In the USA send form by email to Avanos3862@stericycle .com or by FAX to 1-866-324-3738 If consignee is Outside the USA, please send by email to Avanos38620US@stericycle .com or by FAX to +44 0800 069 8520. The consignee should CONTACT Stericycle at 1-888-899-9298 to request the documentation packet needed to return the product. Once the documentation packet is received the customer should follow the instructions on how to return to the product to Avanos (via Stericycle) using the pre-paid label and packing slip provided. Avanos will credit the distributor and send notification to credit the end user. Sold Inventory- If you received any of the impacted products but they are no longer in your inventory IMMEDIATELY COMPLETE the attached Recall Acknowledgement Form checking the box indicating that you have no inventory, then RETURN the form to Avanos. If In the USA send it by email to [email protected] or by FAX to 1-866-324-3738 If outside the USA, customer should send response by email to Avanos38620US@stericycle .com or by FAX to +44 0800 069 8520.

    Distribution

    Worldwide and US Nationwide Distribution: AZ, CA, CT, FL, GA, IA, ID, IL, LA, MO, MN, MD, NY, NM, NV, NJ, OR, OK, OH, RI, TN, TX, WA, WI, ***Foreign: Distributed to Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Romania, United Arab Emirates, United Kingdom

    Quantity

    1766