RegWardenFDA facility compliance records
Recall

Class II — Cardinal Health 200, LLC

Recalling firmCardinal Health 200, LLC
Registered facilityView this company's 35 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
Reasonproducts may be missing a one-way valve on the fluid patient port.
ProductMedi-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 hea…
Quantity3600 units
DistributionUS Distribution to the state of MA
Initiated2018-03-28
Classified2018-04-30
Terminated2018-11-29
Recall numberZ-1546-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-1546-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79702/

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