Recall Z-0667-2022— C.R. Bard Inc

Name: FDA recall Z-0667-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-27

Class II · Ongoing

Class II FDA medical device recall by C.R. Bard Inc, initiated 2022-01-27. It names one FDA 510(k) clearance: K000723. Product: BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C. Reason: There is a potential to leak from the catheter where it connects to the drain bag.

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-01-27
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)Rochester Medical Corp.·cleared 2000-05-19

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 INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

Reason for recall

There is a potential to leak from the catheter where it connects to the drain bag

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