Reported Dec 26, 2012 · Terminated
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the…
Del Mar Reynolds Medical, Ltd.
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: Del Mar Reynolds Medical, Ltd. · 1-2 Harforde Ct., Foxholes · Hertford · N/A
Is this the product you have?
- BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
- Lot codes and dates
- Serial numbers
- for three workstations in the USfocu-101917; focu-101909; and focu-101881. Serial numbers for BleaseFocus
- workstations in other countries
2,278 of 2,278 codes
FOCO-100076FOCO-100077FOCO-100078FOCO-100079FOCO-100080FOCO-100081FOCU-000353FOCU-000354FOCU-000355FOCU-000356FOCU-000357FOCU-000364FOCU-000365FOCU-000405FOCU-000406FOCU-000407FOCU-000408FOCU-000409FOCU-000410FOCU-000411FOCU-000412FOCU-000413FOCU-000414FOCU-000415FOCU-000416FOCU-000417FOCU-000418FOCU-000419FOCU-000420FOCU-000421FOCU-000422FOCU-000423FOCU-000424FOCU-000425focu-000454FOCU-000455FOCU-000456FOCU-000457FOCU-000458FOCU-000459FOCU-000460FOCU-000461FOCU-000462FOCU-000463focu-000464FOCU-000465FOCU-000466FOCU-000467FOCU-000468FOCU-000469FOCU-000470FOCU-000471FOCU-000472FOCU-000473FOCU-000474FOCU-000475FOCU-000476FOCU-000477FOCU-000478FOCU-000479
- for the ventilators in other countries
212 of 212 codes
VENT-001034VENT-001036VENT-001037VENT-001038VENT-001039VENT-001040VENT-001041VENT-001042VENT-001043VENT-001044VENT-001045VENT-001046VENT-001048VENT-001049VENT-001050VENT-001051VENT-001052VENT-001053VENT-001054VENT-001055VENT-001056VENT-001057VENT-001058VENT-001059VENT-001060VENT-001061VENT-001062VENT-001063VENT-001064VENT-001065VENT-001067VENT-001069VENT-001070VENT-001071VENT-001072VENT-001073VENT-001074VENT-001075VENT-001077VENT-001078VENT-001080VENT-001082VENT-001083VENT-001084VENT-001085VENT-001086VENT-001087VENT-001089VENT-001090VENT-001096VENT-001097VENT-001098VENT-001113VENT-001114VENT-001171VENT-001172VENT-001173VENT-001174VENT-001175VENT-001176
- Amount recalled
- 3 in US and 3121 Outside US
Where it was sold
Why it was recalled
The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.
This product could cause temporary or reversible health problems — stop using it.
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