The Recall Desk
HighFDA (Devices)·Z-0754-2024·Announced 2024-01-24

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.

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 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
Hazard
  • suction-loss
  • equipment-malfunction
  • 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 (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.