CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report

Getinge MCC Flow i Disposable CO2 absorber, used recalled

Getinge Us Sales is recalling Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems, distributed nationwide in the US. The recall was initiated on 22 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988

Quantity recalled1444 boxes worldwide

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-2433-2019
FDA event ID: 83468
Recalling firm: Getinge Us Sales, WAYNE, NJ
Classification: Class II
Status: Terminated
Recall initiated: 22 Jul 2019
FDA classified: 30 Aug 2019
Reported: 11 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Jul 2019	Recall initiated by company
30 Aug 2019	Classified by FDA	+39 days
11 Sep 2019	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

Reversed expiration and manufacturing date on the label

Product as listed by the FDA

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

Where it was distributed

US nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Reversed expiration and manufacturing date on the label

Which lots are affected?

Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988

Where was it sold?

US nationwide distribution.

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.

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