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
105816462034272310591647209527241060164821862729117216502554273112011651255527321202165225562733120416532557273512241654255827361225165525592737122616562560273812771657256127391280178625622740128117872613274112821860271427421545186127162743
- Article number 66 77 200 66 77 300 66 77 400 Serial Numbers
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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