Reported Jul 18, 2012 · Terminated
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire…
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 system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
- Lot codes and dates
- Model Number6677300
- Serial Number1170
- Amount recalled
- 284 units
Where it was sold
- Nationwide
- GA
Why it was recalled
Stop using this product now
A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position.
Using this product could cause serious injury, illness or death — stop using it now.
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