The Recall Desk
HighFDA (Devices)·Z-3128-2024·Announced 2024-09-18

Medtronic Venous Cannulae: Wrong Product in Incorrect Packaging

Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.

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 FDA Class II recall involves a manufacturing defect where the wrong medical device was placed in incorrect packaging. No illnesses or injuries have been reported, but the mislabeling and product substitution creates a risk of harm in a surgical application where device specifications are critical.

Plain-English summary

Medtronic Perfusion Systems is recalling Medtronic DLP Single Stage Venous Cannulae with right angle metal tip (Model 67312). During manufacturing, straight-tip cannulae (Model 66118) were incorrectly placed into packaging labeled for the right-angle metal-tip model. A total of 290 units were affected.

The recalled lot numbers are 2023090954 and 202312C065. The products were distributed worldwide, including the United States and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, the United Kingdom, and Vietnam.

Customers who may have received affected units should verify the product model before use. Those with affected devices should contact Medtronic Perfusion Systems for replacement or further guidance.

The recalled product

Product
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Manufacturer
Medtronic Perfusion Systems
Hazard
  • mislabeling
  • product-mix-up

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 (3)

  • GTIN 20613994879329
  • Lot Numbers: 2023090954
  • 202312C065

Distribution

Distributed nationwide across the United States.