Cardinal Health Suction Canister Liners may lose suction due to misalignment
Cardinal Health Medi-Vac suction canister liners in specific lots may lose suction on low settings due to misalignment of the liner with the outer canister. Stop using affected units and contact the manufacturer for replacements.
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: This Class II medical device recall involves a functional loss (suction) that could affect patient care. No injuries, illnesses, or hospitalizations are reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Cardinal Health Medi-Vac CRD 1000 mL Suction Canister Liner Kits with 6 mm 1.8 m tubes (REF 65651-517) are being recalled due to a potential loss of suction functionality. These medical devices are used in healthcare settings to collect patient secretions during suction procedures.
Affected units may experience loss of suction when set to low or low intermittent suction settings. The problem is caused by misalignment of the liner with the outer hard canister, which can prevent proper suction operation. Loss of suction could result in inadequate drainage of secretions, potentially affecting patient care.
The recall involves 74,515 units distributed in the United States, Canada, Australia, and New Zealand. The affected lot numbers are: J308-625, J308-629, J308-637, J309-616, J309-634, J309-646, J309-647, J310-603, and J310-618. Facilities and individuals using these units should discontinue use of the affected lots immediately and contact Cardinal Health 200, LLC for replacement units or alternative options.
The recalled product
- Product
- Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 74,515
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 (10)
- 50630140152670 (case)
- Lot Numbers: J308-625
- J308-629
- J308-637
- J309-616
- J309-634
- J309-646
- J309-647
- J310-603
- J310-618
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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