The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1883-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

Medtronic is recalling 14 tubing packs of its HY10J00R12 perfusion system due to insufficient or incomplete welds. The affected lot is 221227814 with a use-by date of August 28, 2022.

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 recall involving a manufacturing defect (insufficient or incomplete welds) in medical device tubing with potential for device failure. No illnesses or injuries have been reported, placing it within the 'risk-of-harm products where injury has not yet been reported' category.

Plain-English summary

Medtronic Perfusion Systems is recalling 14 tubing packs of its HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System. Specific lots may have been manufactured with insufficient or incomplete welds.

The affected lot is identified by lot number 221227814 and carries a use-by date of August 28, 2022.

These tubing packs were distributed nationwide in the states of Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. No distribution occurred to foreign, government, or military organizations. The FDA has classified this as a Class II recall.

The recalled product

Product
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac Perfusion System
Hazard
Affected units
14

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 00763000467449
  • Lot number 221227814
  • Use By 2022-08-28

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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