Medical device recalls Moderate risk

Cardinal Health 200, LLC recalls Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561…

Recall date
March 28, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1546-2018
FDA classification
Class II
Brand / firm
Cardinal Health 200, LLC
Sold / distributed
US Distribution to the state of MA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).

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