The Recall Desk
HighFDA (Devices)·Z-1882-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

Medtronic is recalling perfusion system tubing packs due to manufacturing defects involving incomplete or insufficient welds. No injuries have been reported, but the defect may affect product performance and safety.

What this means for you

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 a manufacturing defect (incomplete welds) in a perfusion system that poses a structural integrity risk. No adverse events or injuries have been reported, fitting the rubric criterion of a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Perfusion Systems is recalling 12 tubing packs from its CB10W64R1 Custom Pack CH Access 3/8 Custom Perfusion System. The affected product may have been manufactured with insufficient or incomplete welds.

The recalled product was distributed to facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The recall affects lot numbers 221102372 (use by September 21, 2022) and 221672013 (use by November 2, 2022).

The manufacturing defect involves incomplete or insufficient welds. No adverse events or injuries have been reported in connection with this recall.

The recalled product

Product
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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 (5)

  • GTIN 00763000341015
  • Lot numbers 221102372
  • Use By 2022-09-21
  • and 221672013
  • Use By 2022-11-02

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 · weld defect

See all →