The Recall Desk
ModerateFDA (Devices)·Z-1316-2024·Announced 2024-03-27

Medtronic DLP Vessel Cannula Recalled for Incorrect Labeling

Medtronic is recalling 4,343 units of DLP Vessel Cannula (Model REF 30000) due to incorrect labeling on three manufactured lots distributed globally.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a labeling error on an FDA Class II medical device with no reported illnesses or injuries. Per the severity rubric, minor labeling errors without reported harm are classified as Moderate (2).

Plain-English summary

Medtronic Perfusion Systems is recalling 4,343 units of its DLP Vessel Cannula, Model Number REF 30000, due to incorrect labeling affecting three manufactured lots.

The affected lot numbers are 2023020890, 202305C126, and 2023020889. These units were distributed to the United States and internationally to Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, and the United Kingdom.

Healthcare providers and facilities that received affected units should verify that they have received this notice and take appropriate action regarding their inventory.

The recalled product

Product
Medtronic DLP Vessel Cannula, Model Number REF 30000
Manufacturer
Medtronic Perfusion Systems
Hazard
  • mis-labeling

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 (4)

  • UDI/DI 20613994646211
  • Lot Numbers: 2023020890
  • 202305C126
  • 2023020889

Distribution

Distribution scope not specified by the agency.