FDA recall Z-1970-2020

C.R. Bard Inc · Class II · device

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 for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2020-04-15
Report date
2020-05-20
Termination date
2021-05-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1970-2020