The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1891-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

Medtronic is recalling specific lots of CB10Y89R10 custom perfusion system tubing packs due to insufficient or incomplete welds. The affected lots were 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: This is an FDA Class II medical device recall for manufacturing defects (insufficient or incomplete welds) in sterile tubing used during critical surgical procedures. No illnesses or injuries are reported in the source text. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of the CB10Y89R10 Custom Pack ECC 3/8 A/V Custom Perfusion System, a sterile medical device used during extracorporeal circulation procedures. The recalled product consists of 25 tubing packs.

Specific lots may have been manufactured with insufficient or incomplete welds. The affected lot numbers are 221719701 (Use By January 6, 2023) and 221764442 (Use By January 13, 2023).

These tubing packs were distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. There was no foreign, government, or military distribution.

Customers who have these recalled tubing packs should immediately stop using them and contact Medtronic Perfusion Systems for guidance on obtaining replacements or corrections.

The recalled product

Product
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Extracorporeal Circulation / Perfusion
Hazard
Affected units
25

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 00763000499105
  • Lot numbers 221719701
  • Use By 2023-01-06
  • and 221764442
  • Use By 2023-01-13

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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