The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1880-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Defective Welds

Medtronic is recalling specific lots of Custom Pack HY8R62R13 E Pack perfusion system tubing due to manufacturing defects. Affected lots may have incomplete welds that could compromise device function during use.

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 involving a perfusion system used in critical clinical settings. Incomplete welds in the tubing represent a manufacturing defect that could compromise device function during surgical use. No illnesses or injuries have been reported, but the product is classified as a risk-of-harm device.

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of the HY8R62R13 Custom Pack HY8R62R13 E Pack sterile custom perfusion system, consisting of 12 tubing packs per lot, due to manufacturing defects in the welds.

The affected lots may have been manufactured with insufficient or incomplete welds in the tubing packs. These defects could compromise the structural integrity of the tubing and affect proper device function during use.

The recall affects custom perfusion system tubing packs distributed nationwide in the following states: Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The specific affected lot number is 221196141 with a Use By Date of August 19, 2022.

Healthcare providers and facilities using this product should review their inventories and contact Medtronic Perfusion Systems regarding the recall. Do not use affected tubing packs.

The recalled product

Product
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Perfusion System
Hazard
Affected units
12

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 00763000235147
  • Lot number 221196141
  • Use By 2022-08-19

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

See all →

Same hazard · defective welds

See all →

Similar recalls