FDA Device recall Z-0800-2019
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacte…
- FDA Device
- Class II
- ongoing
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacte… by Bard Medical Division, citing some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0800-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-06 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Medical Division |
| Distribution | US |
Product
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
Reason
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
Identifiers
| code_info | Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0800-2019%22
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