Recall Z-1546-2018— Cardinal Health 200, LLC
Class II · Terminated
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2018-03-28, terminated 2018-11-29. FDA's recall record names no specific 510(k) clearance for this event. 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: products may be missing a one-way valve on the fluid patient port..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-28
- Terminated
- 2018-11-29
- Firm location
- Waukegan, IL, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.