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-100076
    • FOCO-100077
    • FOCO-100078
    • FOCO-100079
    • FOCO-100080
    • FOCO-100081
    • FOCU-000353
    • FOCU-000354
    • FOCU-000355
    • FOCU-000356
    • FOCU-000357
    • FOCU-000364
    • FOCU-000365
    • FOCU-000405
    • FOCU-000406
    • FOCU-000407
    • FOCU-000408
    • FOCU-000409
    • FOCU-000410
    • FOCU-000411
    • FOCU-000412
    • FOCU-000413
    • FOCU-000414
    • FOCU-000415
    • FOCU-000416
    • FOCU-000417
    • FOCU-000418
    • FOCU-000419
    • FOCU-000420
    • FOCU-000421
    • FOCU-000422
    • FOCU-000423
    • FOCU-000424
    • FOCU-000425
    • focu-000454
    • FOCU-000455
    • FOCU-000456
    • FOCU-000457
    • FOCU-000458
    • FOCU-000459
    • FOCU-000460
    • FOCU-000461
    • FOCU-000462
    • FOCU-000463
    • focu-000464
    • FOCU-000465
    • FOCU-000466
    • FOCU-000467
    • FOCU-000468
    • FOCU-000469
    • FOCU-000470
    • FOCU-000471
    • FOCU-000472
    • FOCU-000473
    • FOCU-000474
    • FOCU-000475
    • FOCU-000476
    • FOCU-000477
    • FOCU-000478
    • FOCU-000479
  • for the ventilators in other countries

    212 of 212 codes

    • VENT-001034
    • VENT-001036
    • VENT-001037
    • VENT-001038
    • VENT-001039
    • VENT-001040
    • VENT-001041
    • VENT-001042
    • VENT-001043
    • VENT-001044
    • VENT-001045
    • VENT-001046
    • VENT-001048
    • VENT-001049
    • VENT-001050
    • VENT-001051
    • VENT-001052
    • VENT-001053
    • VENT-001054
    • VENT-001055
    • VENT-001056
    • VENT-001057
    • VENT-001058
    • VENT-001059
    • VENT-001060
    • VENT-001061
    • VENT-001062
    • VENT-001063
    • VENT-001064
    • VENT-001065
    • VENT-001067
    • VENT-001069
    • VENT-001070
    • VENT-001071
    • VENT-001072
    • VENT-001073
    • VENT-001074
    • VENT-001075
    • VENT-001077
    • VENT-001078
    • VENT-001080
    • VENT-001082
    • VENT-001083
    • VENT-001084
    • VENT-001085
    • VENT-001086
    • VENT-001087
    • VENT-001089
    • VENT-001090
    • VENT-001096
    • VENT-001097
    • VENT-001098
    • VENT-001113
    • VENT-001114
    • VENT-001171
    • VENT-001172
    • VENT-001173
    • VENT-001174
    • VENT-001175
    • VENT-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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 11, 2013 · Data as of Sep 19, 5:29 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.