The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1879-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Insufficient Welds

Medtronic Perfusion System tubing packs are recalled due to manufacturing defects involving insufficient or incomplete welds in the CB10W63R1 lot. Affected devices may malfunction during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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—a structural manufacturing defect (insufficient welds) in a medical device used in critical procedures—where injury has not yet been reported. FDA Class II classification with no documented hospitalization or injury reports supports a High rating per rubric criteria.

Plain-English summary

Medtronic Perfusion Systems is recalling 15 tubing packs of the CB10W63R1 Custom Pack CB10W63R1 HL 20 1/4 sterile perfusion system. Specific lots of these devices were manufactured with insufficient or incomplete welds, which could compromise the integrity and function of the tubing system during critical medical procedures.

The affected lot number is 221196140, with a use-by date of September 24, 2022. Distribution was limited to US facilities in the following states: Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. No foreign, government, or military distribution occurred.

Medical facilities and professionals who received the affected lot should stop using these devices immediately and contact Medtronic for replacement or remedial action. No injuries or illnesses related to this manufacturing defect have been reported to the FDA to date.

The recalled product

Product
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Perfusion System
Hazard
Affected units
15

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 00763000341039
  • Lot number 221196140
  • Use By 2022-09-24

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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