C.R. Bard Inc: Medical Device Recall in 2020 - (Recall #: Z-1970-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 15, 2020

Date Posted: May 20, 2020

Recall Number: Z-1970-2020

Event ID: 85585

Reason for Recall:

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

Status: Terminated

Product Quantity: 8392 units

Code Information:

Catalog Number: A304716A UDI: 00801741104299 Lot Numbers: NGDX4745 (Exp. 03/20/2021); NGDY0567 (Exp. 03/20/2021); NGDW1548 (Exp. 11/30/2021); NGDW0234 (Exp. 11/30/2021); NGDX4088 (Exp. 11/30/2021); NGDX4704 (Exp. 11/30/2021); NGDY0568 (Exp. 11/30/2021)

Distribution Pattern:

US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.

Voluntary or Mandated:

Voluntary: Firm initiated