Reported Mar 17, 2021 · Terminated
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire…
Getinge Group Logistics America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Getinge Group Logistics America, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Anesthesia gas-machine - Product Usageintended 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
- Lot codes and dates
- UDI CodeFlow 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
1172154620952719 27245427 54296132681912021643 165721862729 27335540 554261336820120417862553 25552735 27475589652568211224 122617872557 25622851 28565590656268221277186026132858 28695812 5814673668231280 1282186127144548 45505895 6737682415452021 202427165198 520360776818694010581059106011671169120120345204 521171854003
- Amount recalled
- 144 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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