Device product
Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
Z-1115-2019
Product summary
- Firm
- Vygon U.S.A.
- Event
- Event 81866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 107700
- Official record key
device-enforcement:Z-1115-2019
Official wording
Reason: DualStop Caps defect causing leaks in affected product
Code information: Lot codes: 090718FD 250118FD 081117FD 130218FD 050418FD 020518FD
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
DualStop Caps defect causing leaks in affected product