Recall Z-1970-2020— C.R. Bard Inc

Name: FDA recall Z-1970-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-15

Class II · Terminated

Class II FDA medical device recall by C.R. Bard Inc, initiated 2020-04-15, terminated 2021-05-20. It names one FDA 510(k) clearance: K040658. Product: SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.. Reason: There is potential for a white paper-type residue attached to the catheter..

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Terminated
Initiated: 2020-04-15
Terminated: 2021-05-20
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

SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Reason for recall

There is potential for a white paper-type residue attached to the catheter.

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