CLASS II Device recall · Reported 17 Mar 2021 · FDA Enforcement Report

Anesthesia gas-machine recalled by Getinge Group Logistics

Getinge Group Logistics America is recalling Anesthesia gas-machine, distributed nationwide in the US. The recall was initiated on 29 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 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, 2735 2747, 5589, 6525, 6821, 1224 1226, 1787, 2557 2562, 2851 2856, 5590, 6562, 6822, 1277, 1860, 2613, 2858 2869, 5812 5814, 6736, 6823, 1280 1282, 1861, 2714, 4548 4550, 5895 6737, 6824, 1545, 2021 2024, 2716, 5198 5203, 6077, 6818, 6940, 1058, 1059, 1060, 1167, 1169, 1201, 2034, 5204 5211, 7185, 4003.

Quantity recalled144 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1181-2021
FDA event ID: 87301
Recalling firm: Getinge Group Logistics America, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 29 Jan 2021
FDA classified: 5 Mar 2021
Reported: 17 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

29 Jan 2021	Recall initiated by company
5 Mar 2021	Classified by FDA	+35 days
17 Mar 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, MA, MI, MO, NJ, NY, OH, OR, PA, TX, VA, WA, WV.

Nationwide Alabama Arkansas Arizona California Colorado Florida Georgia Massachusetts Michigan Missouri New Jersey New York Ohio Oregon Pennsylvania Texas Virginia Washington West Virginia

Questions about this recall

Is Anesthesia gas-machine recalled?

Yes. Getinge Group Logistics America recalled Anesthesia gas-machine on 29 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1181-2021.

Why was it recalled?

Which lots are affected?

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, 2735 2747, 5589, 6525, 6821, 1224 1226, 1787, 2557 2562, 2851 2856, 5590, 6562, 6822, 1277, 1860, 2613, 2858 2869, 5812 5814, 6736, 6823, 1280 1282, 1861, 2714, 4548 4550, 5895 6737, 6824, 1545, 2021 2024, 2716, 5198 5203, 6077, 6818, 6940, 1058, 1059, 1060, 1167, 1169, 1201, 2034, 5204 5211, 7185, 4003.

Where was it sold?

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, MA, MI, MO, NJ, NY, OH, OR, PA, TX, VA, WA, WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Getinge Group Logistics America

All 4

Reported	Class	Recall	Company	Reason	Where
31 Mar 2021Device	CLASS II	Operating Table System recalled by Getinge Group Logistics	Getinge Group Logistics America	Lead & Heavy Metals	42 states
24 Feb 2021Device	CLASS II	Getinge CM320 Series Washer Disinfector recalled	Getinge Group Logistics America	Foreign Material	Nationwide
21 Oct 2020Device	CLASS II	Servo-i Ventilator recalled by Getinge Group Logistics	Getinge Group Logistics America	Other	15 states

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