Reported Jun 17, 2015 · Terminated

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on…

Maquet Cardiovascular US Sales, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470

Is this the product you have?

  • FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Lot codes and dates
  • Article number 66 77 200 66 77 300 66 77 400 Serial Numbers

    76 of 76 codes

    • 1058
    • 1646
    • 2034
    • 2723
    • 1059
    • 1647
    • 2095
    • 2724
    • 1060
    • 1648
    • 2186
    • 2729
    • 1172
    • 1650
    • 2554
    • 2731
    • 1201
    • 1651
    • 2555
    • 2732
    • 1202
    • 1652
    • 2556
    • 2733
    • 1204
    • 1653
    • 2557
    • 2735
    • 1224
    • 1654
    • 2558
    • 2736
    • 1225
    • 1655
    • 2559
    • 2737
    • 1226
    • 1656
    • 2560
    • 2738
    • 1277
    • 1657
    • 2561
    • 2739
    • 1280
    • 1786
    • 2562
    • 2740
    • 1281
    • 1787
    • 2613
    • 2741
    • 1282
    • 1860
    • 2714
    • 2742
    • 1545
    • 1861
    • 2716
    • 2743
Amount recalled
1641 [80 units (US) 1561 units (OUS)]

Where it was sold

Why it was recalled

Stop using this product now

In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 6, 2016 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.