The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1876-2021·Announced 2021-06-23

Medtronic Custom Perfusion System Tubing Packs Recalled for Weld Defects

Medtronic recalls custom perfusion system tubing packs due to potential manufacturing defects in welds. Specific lots may have insufficient or incomplete welds that could affect system integrity.

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 an FDA Class II medical device recall for a manufacturing defect (weld quality) in surgical equipment. No illnesses or injuries have been reported. Per rubric criteria, Class II recalls score as High (3) when no hospitalization reports exist and the hazard remains theoretical.

Plain-English summary

Medtronic Perfusion Systems has recalled specific lots of its Custom Pack CB7J97R8 U14 E Sup Custom Perfusion System Sterile tubing packs. The recall was initiated because certain lots may have been manufactured with insufficient or incomplete welds.

The affected product was distributed nationwide to healthcare facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. Two specific lot numbers are subject to this recall: lot 220866440 (Use By 2022-07-10) and lot 221451579 (Use By 2022-10-24).

Healthcare providers should identify any affected tubing packs by their lot number and use-by date. Units with these lot numbers should be removed from service immediately. Facilities should contact Medtronic Perfusion Systems for additional information and guidance on this recall.

The recalled product

Product
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Perfusion System
Hazard
Affected units
10

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 (5)

  • GTIN 00643169641228
  • Lot numbers 220866440
  • Use By 2022-07-10
  • and 221451579
  • Use By 2022-10-24

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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