Recall Z-2154-2024— C.R. Bard Inc

Name: FDA recall Z-2154-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-09

Class II · Ongoing

Class II FDA medical device recall by C.R. Bard Inc, initiated 2024-05-09. It names one FDA 510(k) clearance: K040658. Product: 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.. Reason: Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices..

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-05-09
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K040658 — BARDEX I.C. LATEX FOLEY CATHETERC.R. Bard, Inc.·cleared 2004-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.