Z-0887-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2025
- Initiation Date
- November 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1240
Product Description
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Code Information
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130