Suction Canister Liner Recalled for Loss of Suction on Low Settings
Cardinal Health Suction Canister Liners may lose suction on low or intermittent settings due to liner misalignment. Approximately 3.5 million units are affected across the US, Canada, Australia, and New Zealand.
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 is a risk-of-harm product where injury has not been reported. The liner misalignment could prevent proper suctioning during medical procedures, but no illnesses or injuries are documented in the source material.
Plain-English summary
Cardinal Health Suction Canister Liners (MEDI-VAC CRD, REF 65651-510) are being recalled because the liner may become misaligned with the outer hard canister, causing loss of suction on low or intermittent suction settings. This defect affects approximately 3.5 million units.
The specific lot numbers affected are: J308-602, J308-605, J308-609, J308-623, J308-624, J308-625, J308-628, J308-629, J308-630, J308-632, J308-633, J308-634, J308-635, J308-636, J308-637, J308-640, J308-642, J308-607, J308-643, J309-603, J309-607, J309-623, J309-627, J309-630, J309-632, J309-635, J309-636, J309-637, J310-601, J310-609, J310-621, J310-622, J310-626, J310-627, J310-641, J310-642, J310-643, J310-644.
The misalignment defect could prevent proper suctioning during medical procedures where low or intermittent suction is required. Affected units were distributed in the US, Canada, Australia, and New Zealand. Medical facilities and healthcare providers should check their inventory against the affected lot numbers and contact Cardinal Health for further guidance or product replacement options.
The recalled product
- Product
- CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 3,505,730
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 (20)
- UDI/DI 50630140152649 (case)
- Lot Numbers: J308-602
- J308-605
- J308-609
- J308-623
- J308-624
- J308-625
- J308-628
- J308-629
- J308-630
- J308-632
- J308-633
- J308-634
- J308-635
- J308-636
- J308-637
- J308-640
- J308-642
- J308-607
- J308-643
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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