BEUDAMED
    FDA Recall Terminated

    Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory

    Recall: Z-0195-2023 · Initiated September 14, 2022

    Recall

    Recall Number
    Z-0195-2023
    Event Number
    90964
    Firm
    Avanos Medical, Inc.
    FEI Number
    3011270181
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    September 14, 2022
    Posted
    November 8, 2022
    Terminated
    August 31, 2023
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory

    Reason

    Sterile extension sets were distributed without an expiration date

    Action

    AVANOS sent an URGENT: FIELD CORRECTION on 09/15/2022 via overnight FedEx to customers. The letter explained the issue and requested the following: "WHAT SHOULD I DO IN RESPONSE TO THIS FIELD CORRECTION? Our records show that you and/or your facility have received one or more of the impacted products. Avanos requests that you take the following actions: " CHECK all storage and usage locations to determine if any impacted product remains within your possession and QUARANTINE all impacted product identified. " COMPLETE and RETURN the attached Acknowledgement Form (Attachment 1) to Avanos. o Via email to [email protected] , subject line FCA-2022-007 Hospital Acknowledgement Form o Avanos Customer Service will contact you regarding product return Please respond within five (5) business days of receipt of this letter. If you have questions or require further assistance, please contact Avanos via email at [email protected]." The firm sent updated letters the week of October 10, 2022. The letters titled, "URGENT: PRODUCT RECALL" provided updated product descriptions.

    Distribution

    US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI

    Quantity

    1378 units