C.R. Bard Inc: Device Recall

Recall #Z-2462-2025 · 06/18/2025

Class II: Risk

Recall Details

Recall Number
Z-2462-2025
Classification
Class II
Product Type
Device
Recalling Firm
C.R. Bard Inc
Status
Ongoing
Date Initiated
06/18/2025
Location
Covington, GA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
175,158

Reason for Recall

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.

Product 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

Distribution Pattern

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.

Other Recalls by C.R. Bard Inc

View all recalls by C.R. Bard Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.