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U.S. Department of Health and Human Services

Class 2 Device Recall Flowi Anesthesia System, Flowc Anesthesia System, Flowe Anesthesia System

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 Class 2 Device Recall Flowi Anesthesia System, Flowc Anesthesia System, Flowe Anesthesia Systemsee related information
Date Initiated by FirmJanuary 29, 2021
Create DateMarch 05, 2021
Recall Status1 Terminated 3 on September 28, 2023
Recall NumberZ-1181-2021
Recall Event ID 87301
510(K)NumberK191027 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductAnesthesia 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.
Code Information 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.   
Recalling Firm/
Manufacturer		 Getinge Group Logistics America, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactRachana Patel
973-709-7412
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 2/9/2021 Maquet Critical Care AB / Getinge issued an Urgent Medical Device Correction letter via FedEx for the Flow i anesthesia machine due to the potential for high FiCO2 values and/or a System Check Out failure due to an incomplete docking of the CO2 absorber to the patient cassette. The patients re-breathing without CO2 reduction could occur if the absorber is not sufficiently docked.
Quantity in Commerce144 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BSZ
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