SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A319514ARecalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Lubri-Sil® IC Complete Care® Temperature Sensing Foley Catheter Tray 350 ml Urine Meter · Class 2
All models of SureStep Foley Tray System Lubri-Sil IC Complete Care (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jun 18, 2025Class IIOpen, Classified
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Z-2462-2025 · Root cause: Process design · Recall details · FDA record ↗
Other CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES devices
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119314C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall3,889 reports
- Bardex® I.C. Foley Catheter 0165SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,994 reports
- Bardex® I.C. Foley Catheter 0165SI16C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,052 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES778 reports
- Bardex® I.C. Temperature Sensing Foley Catheter 129414MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES436 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119316MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES231 reports
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119316C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES198 reports
- Bardex® I.C. Foley Catheter 0165SI18C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES181 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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