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.
Z-1970-2020
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 85585
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8392 units
- Official record key
device-enforcement:Z-1970-2020
Official wording
Reason: There is potential for a white paper-type residue attached to the catheter.
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.
Derived failure modes
-
Unknown
There is potential for a white paper-type residue attached to the catheter.