Device product
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
Z-1546-2018
Product summary
- Event
- Event 79702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3600 units
- Official record key
device-enforcement:Z-1546-2018
Official wording
Reason: products may be missing a one-way valve on the fluid patient port.
Code information: a) REF 6561-910C, Lot Numbers: J802-384, J802-391 b) REF 6561-916K, Lot Number: J802-386 c) REF 6561-920C, Lot Number: J802-396
Distribution pattern: US Distribution to the state of MA
Derived failure modes
-
Unknown
products may be missing a one-way valve on the fluid patient port.