The Recall Desk
HighFDA (Devices)·Z-1887-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Defective Welding

Medtronic has recalled 16 tubing packs from its CB10R79R6 Custom Perfusion System due to insufficient or incomplete welds in specific lots. The defect may compromise device integrity during use.

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 Class II medical device recall with no reported illnesses or injuries. The hazard—incomplete welds that may compromise device integrity—represents a risk of harm if the device fails during use, meeting the criterion for High severity.

Plain-English summary

Medtronic Perfusion Systems has recalled 16 tubing packs of the CB10R79R6 Custom Pack 1/4X1/4 Loop, a sterile perfusion system. Specific lots were manufactured with insufficient or incomplete welds.

Incomplete or insufficient welds may compromise the integrity of the device. This is an FDA Class II device recall.

The affected product was distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The recall involves Lot 221451543, with a Use By date of October 22, 2022.

Anyone who has received affected tubing packs should stop using them and contact Medtronic Perfusion Systems for information about device replacement or return.

The recalled product

Product
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Perfusion System
Hazard
Affected units
16

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 00763000360436
  • Lot number 221451543
  • Use By 2022-10-22

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 25 recalled by Medtronic Perfusion Systems 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.

See all 25 products in this recall →

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