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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
Similar recalls
- HighCardinal Health Suction Canister Liners may lose suction due to misalignment
FDA (Devices) · 2024-01-24
- HighSuction Canister Liners Recalled for Potential Loss of Suction Function
FDA (Devices) · 2024-01-24
- HighSuction Canister Liner Recalled for Loss of Suction on Low Settings
FDA (Devices) · 2024-01-24
- HighMedline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction
FDA (Devices) · 2024-09-18
- SevereMedline Recalls Semi-Rigid Suction Liners Due to Suction Loss
FDA (Devices) · 2024-09-18
- HighMedline Surgical Suction Liners Recalled for Potential Loss of Suction
FDA (Devices) · 2024-09-18