The Recall Desk
HighFDA (Devices)·Z-1895-2021·Announced 2021-06-23

Medtronic Neonatal Perfusion System Tubing Sets Recalled for Incomplete Welds

Medtronic is recalling 7 neonatal perfusion system tubing sets manufactured under lot 221387901 with insufficient or incomplete welds. The affected sets were distributed nationwide across nine states.

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: FDA Class II medical device recall with no reported deaths, hospitalizations, or injuries. The incomplete welds constitute a manufacturing defect in a neonatal perfusion system, a risk-of-harm device. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a High (Score 3) rating.

Plain-English summary

Medtronic Perfusion Systems is recalling 7 tubing sets from its 1A46R11 Neonatal Custom Perfusion System. The recall affects units manufactured under lot number 221387901, with a Use By date of December 16, 2022, identified by GTIN 00643169947436.

The recalled tubing sets may have been manufactured with insufficient or incomplete welds.

The affected sets were distributed in nine states: Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. There was no distribution to foreign, government, or military locations.

Patients and healthcare facilities with potentially affected tubing sets should contact Medtronic Perfusion Systems or their healthcare provider regarding this recall.

The recalled product

Product
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Neonatal Perfusion System
Hazard
Affected units
7

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 00643169947436
  • Lot number 221387901
  • Use By 2022-12-16

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

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Same hazard · incomplete weld

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