BEUDAMED
    FDA Enforcement Class II Ongoing

    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S

    Recall: Z-2462-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2462-2025
    Event ID
    97041
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    C.R. Bard Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2025
    Initiation Date
    June 18, 2025
    Classification Date
    August 28, 2025
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497, United States

    Description

    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S

    Reason

    Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.

    Code Info

    Catalog/UDI-DI/Lot(Expiration): 119314/00801741039843, 10801741039840/NGJS3588(31/03/2029), NGKQ2500(21/12/2029), NGKQ0170(30/11/2029), NGJW2499(31/08/2029), NGJT1284 (31/03/2029), NGKQ2492(31/12/2029), NGKP3152(31/12/2029), NGJX0215(31/07/2029). A319514A/00801741100321, 10801741100328/NGJN0498(31/01/2026), NGJW3127(30/04/2027) 29000J14/21200BZY00110000/MYJX0683(28/05/2027), MYJP0751(28/02/2027), MYJR1984(28/04/2027), MYJQ0070(28/04/2027), MYJS6278(28/04/2027), MYJR3026(28/04/2027), MYJT3766(28/04/2027), MYJY6197(28/06/2027), MYJX2833(28/06/2027), MYJQ4022(28/04/2027), MYJT3764(28/04/2027), MYJZ0962(28/06/2027), MYJS4679(28/04/2027), MYJX0686(28/06/2027), MYJV4359(28/03/2027), MYJS3597(28/04/2027), MYJW1900(28/04/2027), MYJT3765(28/04/2027), MYJY1245(28/06/2027), MYJY1242(28/06/2027), MYJY1248(28/06/2027). 29030J14/21200BZY00110000/MYJX2846(28/06/2027), MYJP2013(28/02/2027), MYJT1017(28/04/2027), MYJW1906(28/04/2027), MYJT4535(28/07/2027), MYJP4407(28/04/2027), MYJS1895(28/04/2027), MYJW1904(28/04/2027), MYJV4102(28/03/2027), MYJX2836(28/05/2027), MYJZ4526(28/06/2027), MYJT3468(28/04/2027), MYJP2012(28/02/2027), MYJV4099(28/03/2027), MYJZ0964(28/06/2027), MYJQ0071(28/04/2027), MYJS6279(28/04/2027), MYJY4511(28/06/2027), MYJQ4024(28/04/2027), MYJZ0963(28/06/2027), MYJT1018(28/04/2027), MYJR3027(28/04/2027), MYJS3599(28/04/2027), MYJQ4023(28/04/2027), MYJR3083(28/04/2027), MYJY4512(28/06/2027), MYJQ0073(28/04/2027), MYJS1893(28/04/2027), MYJN2580(28/01/2027), MYJU2705(28/08/2027), MYJZ4527(28/06/2027), MYJS1894(28/04/2027), MYJV4103(28/03/2027), MYJR3059(28/04/2027), MYJU0772(28/08/2027), MYJV4101(28/03/2027), MYJY4513(28/06/2027), MYJQ0072(28/04/2027), MYJU3846(28/03/2027), MYJU3847(28/05/2027), MYJX2841(28/06/2027), MYJX2840(28/05/2027), MYJX2839(28/05/2027), MYJY4510(28/06/2027), MYJY4509(28/06/2027), MYJV4100(28/06/2027), MYJU3848(28/06/2027). 29000J14S/21200BZY00110000/MYJY1249(28/06/2027), MYJY0937(28/05/2027), MYJW1903(28/03/2027). 29030J14S/21200BZY00110000/MYJU0773(28/08/2027)

    Distribution

    Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan.

    Quantity

    175,158