Device product
Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
Z-1114-2019
Product summary
- Firm
- Vygon U.S.A.
- Event
- Event 81866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 339,800
- Official record key
device-enforcement:Z-1114-2019
Official wording
Reason: DualStop Caps defect causing leaks in affected product
Code information: Lot codes: 310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
DualStop Caps defect causing leaks in affected product