FDA Enforcement
Class II
Ongoing
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Recall: Z-0887-2026
·
Reported December 17, 2025
Enforcement
- Recall Number
- Z-0887-2026
- Event ID
- 97864
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Bard Peripheral Vascular Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- December 17, 2025
- Initiation Date
- November 6, 2025
- Classification Date
- December 5, 2025
- Address
- 1625 W 3rd St Bldg 1, 850 W. Rio Salado Prkwy., Tempe, AZ, 85281-2438, United States
Description
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Reason
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.
Code Info
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Distribution
US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Quantity
1240