Device product
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Z-0887-2026
Product summary
- Event
- Event 97864
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1240
- Official record key
device-enforcement:Z-0887-2026
Official wording
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 information: UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Distribution pattern: US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Derived failure modes
-
Unknown
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.