C.R. Bard Inc: Device Recall

Recall Details

Recall Number

Z-2154-2024

Classification

Class II

Product Type

Device

Recalling Firm

C.R. Bard Inc

Status

Ongoing

Date Initiated

05/09/2024

Location

Covington, GA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

6,420 devices

Reason for Recall

Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

Product Description

Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.

Distribution Pattern

Distribution was nationwide. There was no government/military/foreign distribution.

Other Recalls by C.R. Bard Inc

• Class II: Risk 11/06/2025
  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
• Class II: Risk 11/06/2025
  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
• Class II: Risk 11/06/2025
  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
• Class II: Risk 11/06/2025
  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
• Class II: Risk 07/17/2025
  Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

View all recalls by C.R. Bard Inc →