C.R. Bard Inc recalls SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of ur…

Recall date

April 15, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1970-2020

FDA classification

Class II

Brand / firm

C.R. Bard Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.