Agency classClass IIOur severity:High FDA (Devices)·Z-1890-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.

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: FDA Class II medical device with a manufacturing defect (incomplete/insufficient welds) in a critical surgical application. No illnesses or injuries have been reported, placing this in the 'risk-of-harm' category where injury has not yet been reported.

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of the HY10L28R3 Custom Pack perfusion system, a sterile, prescription-only medical device consisting of 5 tubing packs. Lot number 221679870, with a use-by date of December 3, 2022, has been recalled.

The recall was initiated because manufacturing defects were identified in specific lots. The affected units may have been manufactured with insufficient or incomplete welds.

Affected units were distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. Healthcare providers using these devices should verify whether they have affected product from lot 221679870.

For further information or to arrange for replacement, contact Medtronic Perfusion Systems.

The recalled product

Product: Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Cardiac Perfusion
Hazard: weld-defect
device-failure
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 00763000156879
Lot number 221679870
Use By 2022-12-03

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 →

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · weld defect