FDA recall Z-1546-2018

Cardinal Health 200, LLC · Class II · 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).

Reason for recall

products may be missing a one-way valve on the fluid patient port.

Distribution

US Distribution to the state of MA

Key facts

Status
Terminated
Initiation date
2018-03-28
Report date
2018-05-09
Termination date
2018-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1546-2018