The Recall Desk
HighFDA (Devices)·Z-1889-2021·Announced 2021-06-23

Medtronic perfusion system tubing packs recalled due to weld defects

Medtronic is recalling specific lots of CB7J98R7 Custom Pack perfusion system tubing because some units may have insufficient or incomplete welds. The defect could affect device performance during cardiac surgery.

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 FDA medical device recall with no reported injuries, illnesses, or hospitalizations. The hazard—insufficient or incomplete welds in a perfusion system used during cardiac surgery—represents a potential risk to patient safety. Per the rubric, risk-of-harm products without reported injury are scored at 3 (High).

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of the CB7J98R7 Custom Pack perfusion system tubing packs due to a manufacturing defect. The recalled tubing packs may have been manufactured with insufficient or incomplete welds.

Incomplete or insufficient welds could compromise the integrity of the tubing system, which could affect proper fluid delivery during cardiac surgical procedures.

The recall affects 3 tubing packs with lot number 221575680 and a use-by date of November 20, 2022. Distribution was nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.

Healthcare facilities and surgical centers that have these specific lot numbers should discontinue use immediately and contact Medtronic for replacement tubing packs or further instructions. No injuries or adverse events have been reported to date.

The recalled product

Product
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac Surgery Equipment
Hazard
  • weld-defect

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 00643169640870
  • Lot number 221575680
  • Use By 2022-11-20

Distribution

Distributed nationwide across the United States.

Related recalls

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