Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 06, 2025 |
| Reported | December 17, 2025 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Country / region | United States AZ |
Hazard
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Affected products
- Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Related recalls
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vaSwan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros;