The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1873-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

Medtronic is recalling specific lots of BB10R94R6 Custom Perfusion System tubing packs due to incomplete or insufficient welds. The defect may affect device performance 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: FDA Class II medical device recall for incomplete welds in a critical-use perfusion system. No illnesses or injuries have been reported, placing this at High severity per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of its BB10R94R6 Custom Pack 1/4 ECCPK Custom Perfusion System. This sterile medical device is used for extracorporeal circulation during cardiac procedures. The recall affects approximately 10 tubing packs distributed nationwide in the states of Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.

The recall was initiated due to the potential for incomplete or insufficient welds in affected units. Specific lot numbers 221102356 (Use By 2022-10-09) and 221672011 (Use By 2022-10-22) may have been manufactured with this defect.

Healthcare facilities and medical professionals using this product should immediately check their inventory against the affected lot numbers. Do not use affected units. Contact Medtronic Perfusion Systems for replacement stock or disposal instructions.

The recalled product

Product
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, 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 00763000258016
  • Lot numbers 221102356
  • Use By 2022-10-09
  • and 221672011
  • Use By 2022-10-22

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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