Reported May 9, 2018 · Terminated

Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers

Cardinal Health 200, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337

Is this the product you have?

Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers

3 of 3 products

Products covered by this recall
Model / numberProduct as published
6561-910C
6561-916K
6561-920CTo 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).
Lot codes and dates
  • a) REF 6561-910C
  • Lot Numbers
    • J802-384
    • J802-391 b) REF 6561-916K
  • Lot NumberJ802-386 c) REF 6561-920C
  • Lot NumberJ802-396
Amount recalled
3600 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 29, 2018 · Data as of Sep 19, 6:16 PM UTC

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