The Recall Desk
HighFDA (Devices)·Z-1888-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Defective Welds

Medtronic is recalling CB10R55R5 perfusion system tubing packs due to insufficient or incomplete welds that could compromise device function. The recall affects five tubing packs distributed across nine U.S. states.

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: FDA Class II medical device recall for a structural defect (insufficient or incomplete welds) in tubing packs used in surgical procedures. The risk-of-harm from device malfunction during critical surgical use qualifies as a risk-of-harm product per the rubric.

Plain-English summary

Medtronic Perfusion Systems is recalling CB10R55R5 Custom Pack CB10R55R5 3/8X3/8 Loop perfusion system tubing packs due to manufacturing defects. The recalled devices may have been manufactured with insufficient or incomplete welds.

Perfusion systems are sterile, prescription medical devices used in surgical procedures. Defective welds could compromise the structural integrity and proper function of the tubing system during critical medical procedures.

The recall affects five tubing packs with lot number 221542968 (use-by date: November 6, 2022). The devices were distributed nationwide to facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.

The recalled product

Product
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Surgical / Perfusion Equipment
Hazard
Affected units
5

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 00763000360443
  • Lot number 221542968
  • Use By 2022-11-06

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 →

Related recalls

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · weld defect

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