The Recall Desk
ModerateFDA (Devices)·Z-1962-2012·Announced 2012-07-18

Terumo Advanced Perfusion System 1 Gas System Recall for Flow Control Issues

Terumo is recalling 1,095 units of the Advanced Perfusion System 1 Electronic O2 Blender/Analyzer due to reported difficulty adjusting the local flow control knob.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific issue is a mechanical difficulty in adjusting a control knob, which does not meet the criteria for Severe (Class II with hospitalization) or High (risk of harm without reported injury).

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 1,095 units of the Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The device is used to control and monitor gas flow rates and oxygen content in perfusion circuits. The recall is limited to units with catalog number 801188 and specific serial numbers ranging from 0001-0006 to 01160-01164.

The recall was initiated after Terumo received two complaints regarding the Gas System. In both instances, users reported experiencing difficulty adjusting the System 1 Gas System local flow control knob. The affected units were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Belgium, Canada, and Germany.

Healthcare facilities and users should identify any affected units by checking the catalog and serial numbers. Terumo is the recalling firm and is responsible for managing the recall process for these devices.

The recalled product

Product
Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Perfusion Equipment
Hazard
Affected units
1,095

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 (20)

  • catalog number: 801188 and Serial numbers: 0001-0006
  • 0008-00050
  • 00052-00123
  • 00125-00152
  • 00154-0174
  • 00176-00211
  • 00213-00241
  • 00245-00250
  • 00300-00356
  • 00358-00365
  • 00367-00449
  • 00451-00489
  • 00492-00522
  • 00524-00531
  • 00533-00649
  • 00651-00660
  • 00662-00825
  • 0826-0830
  • 00831-01157
  • and 01160-01164.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Terumo Cardiovascular Systems Corporation 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 3 products in this recall →

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