FDA Device recall Z-2154-2024
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM
- FDA Device
- Class II
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM by C R Bard, citing some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2154-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-09 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | C R Bard |
| Distribution | US |
Product
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.
Reason
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Identifiers
| code_info | SureStep Foley Tray System - Lot #NGHZ1757, exp. 31Jan2026, UDI-DI 00801741073861 (eaches); 10801741073868 (case). Bar…SureStep Foley Tray System - Lot #NGHZ1757, exp. 31Jan2026, UDI-DI 00801741073861 (eaches); 10801741073868 (case). Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray, Lot #NGHX2932, exp. 31May2025, UDI-DI 00801741024450 (each); 10801741024457 (case). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by C R Bard
- Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 108017411…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes:…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 0…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08…
FDA Device · Class II · 2026-09-16 · C R Bard
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2154-2024%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.