The Recall Desk
HighFDA (Devices)·Z-1546-2018·Announced 2018-05-09

Medi-Vac Suction Canister Liners Recalled for Missing Valve

Cardinal Health is recalling 3,600 Medi-Vac Flex Advantage Suction Canister Liners distributed in Massachusetts because they may be missing a one-way valve.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect (missing valve) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling 3,600 units of Medi-Vac Flex Advantage Suction Canister Liners. The affected products are identified by Material Numbers REF 6561-910C, REF 6561-916K, and REF 6561-920C, with specific lot numbers J802-384, J802-391, J802-386, and J802-396. These liners are used in operating rooms and patient suites to collect blood and body fluids during surgical procedures and other medical applications.

The recall was initiated because the products may be missing a one-way valve on the fluid patient port. This defect could potentially affect the function of the suction canister during use. The affected units were distributed to the state of Massachusetts.

Healthcare facilities and consumers should check their inventory for the specific material and lot numbers listed above. If the products are found, they should be removed from service and returned to the manufacturer or disposed of according to local regulations.

The recalled product

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
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Suction Equipment
Hazard
Affected units
3,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • a) REF 6561-910C
  • Lot Numbers: J802-384
  • J802-391 b) REF 6561-916K
  • Lot Number: J802-386 c) REF 6561-920C
  • Lot Number: J802-396

Distribution

Distributed in 1 state:

Related recalls

Same manufacturer · Cardinal Health 200, LLC

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