Recall Z-0800-2019— Bard Medical Division

Name: FDA recall Z-0800-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-06

Class II · Ongoing

Class II FDA medical device recall by Bard Medical Division, initiated 2018-12-06. It names one FDA 510(k) clearance: K910318. Product: BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.. Reason: Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port..

Recalling firm: Bard Medical Division
Classification: Class II
Status: Ongoing
Initiated: 2018-12-06
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K910318 — BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETERC.R. Bard, Inc.·cleared 1994-08-18

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 SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.

Reason for recall

Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.

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