The Recall Desk
HighFDA (Devices)·Z-1181-2021·Announced 2021-03-17

Getinge Flow i Anesthesia Systems Recalled for Absorber Docking Failures

Getinge Group Logistics America is recalling 144 Flow i Anesthesia Systems due to complaints of incorrect FiCO2 readings and System Check Out failures when docking the absorber.

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: The recall involves a high-risk medical device (anesthesia machine) where a defect could lead to patient harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Getinge Group Logistics America, LLC is recalling 144 units of Flow i Anesthesia Systems. These devices are intended for administering anesthesia while controlling the ventilation of patients with no ability to breathe, as well as supporting patients with limited ability to breathe. The affected models include the Flow i C20, C30, C40, and Flow c Anesthesia Systems.

The recall was initiated after Maquet Critical Care AB received complaints that the FiCO2 value was not zero or as close to zero as expected. Additionally, users experienced System Check Out failures when docking the absorber to the anesthesia machine.

The affected units were distributed nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, MA, MI, MO, NJ, NY, OH, OR, PA, TX, VA, WA, and WV. Specific serial numbers are listed in the official recall documentation. Users should contact the manufacturer for further instructions on how to proceed with the recall.

The recalled product

Product
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
Affected units
144

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)

  • UDI Code: Flow i C20 Anesthesia System 6677200 07325710001349
  • Flow i C30 Anesthesia System 6677300 07325710001349
  • Flow i C40 Anesthesia System 6677400 07325710001318
  • Flow c Anesthesia System 6887700 07325710009765 Serial Number: 1172
  • 1546
  • 2095
  • 2719 2724
  • 5427 5429
  • 6132
  • 6819
  • 1202
  • 1643 1657
  • 2186
  • 2729 2733
  • 5540 5542
  • 6133
  • 6820
  • 1204
  • 1786
  • 2553 2555

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Same manufacturer · Getinge Group Logistics America, LLC

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