Device product
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
Z-0695-2018
Product summary
- Event
- Event 79117
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,678
- Official record key
device-enforcement:Z-0695-2018
Official wording
Reason: Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Code information: Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection