Suction Canister Liners Recalled for Potential Loss of Suction Function
Cardinal Health suction canister liners may lose suction on low settings due to liner misalignment. Approximately 203,244 units distributed to the US, Canada, Australia, and New Zealand.
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: This is an FDA Class II medical device recall for a functional defect (loss of suction) that represents a risk of harm in clinical settings. No illnesses or injuries have been reported, placing it in the High severity category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health MEDI-VAC CRD Suction Canister Liners (1000 mL, REF 65651-516) are the subject of this recall. Approximately 203,244 units have been distributed to the United States, Canada, Australia, and New Zealand.
The affected units may experience loss of suction when used on low or low intermittent suction settings. The issue is caused by misalignment of the liner with the outer hard canister. Affected lot numbers include J308-606, J308-624, J308-628, J308-642, J308-643, J309-608, J309-610, J309-622, J309-626, J309-633, J309-645, J310-602, J310-617, and J310-645.
Customers with affected lot numbers should verify their product lot number and contact Cardinal Health 200, LLC, the manufacturer, for further information regarding this recall and product replacement options.
The recalled product
- Product
- Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- suction-loss
- misalignment
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 (14)
- 50630140152633 (case)
- Lot Numbers: J308-606
- J308-624
- J308-628 J308-642
- J308-643
- J309-608
- J309-610
- J309-622
- J309-626
- J309-633
- J309-645
- J310-602
- J310-617
- J310-645
Distribution
Distribution scope not specified by the agency.
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