FDA Device recall Z-1970-2020
SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine by C R Bard, citing there is potential for a white paper-type residue attached to the catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1970-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-15 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | C R Bard |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Number: A304716A UDI: 00801741104299 Lot Numbers: NGDX4745 (Exp. 03/20/2021); NGDY0567 (Exp. 03/20/2021); NGD…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.