FDAFDA · Food and drugs·Recall number Z-0565-2013
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.
Published December 26, 2012 · Recall initiated: November 2, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
- Distributor
- Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates , Uruguay, Venezuela, and Vietnam.
- Lot
- Serial numbers for three workstations in the US: focu-101917; focu-101909; and focu-101881. Serial numbers for BleaseFocus workstations in other countries: 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, FOCU-000480, FOCU-000481, FOCU-000482, FOCU-000483, FOCU-000484, FOCU-000485, FOCU-000486, FOCU-000487, FOCU-000488, FOCU-000489, FOCU-000490, FOCU-000491, FOCU-000492, FOCU-000493, FOCU-000494, FOCU-000495, FOCU-000496, FOCU-000497, FOCU-000498, FOCU-000499, FOCU-000500, FOCU-000501, FOCU-000502, FOCU-000503, FOCU-000504, FOCU-000505, FOCU-000506, FOCU-000507, FOCU-000508, FOCU-000509, FOCU-000510, FOCU-000511, FOCU-000512, FOCU-000513, FOCU-000514, FOCU-000515, FOCU-000516, FOCU-000517, FOCU-000518, FOCU-000519, FOCU-000520, FOCU-000521, FOCU-000522, FOCU-000523, FOCU-000524, FOCU-000525, FOCU-000526, FOCU-000527, FOCU-000528, FOCU-000529, FOCU-000530, FOCU-000531, FOCU-000532, FOCU-000533, FOCU-000534, FOCU-000535, FOCU-000536, FOCU-000537, FOCU-000538, FOCU-000539, FOCU-000540, FOCU-000541, FOCU-000542, FOCU-000543, FOCU-000544, FOCU-000545, FOCU-000546, FOCU-000547, FOCU-000548, FOCU-000549, FOCU-000550, FOCU-000551, FOCU-000552, FOCU-000553, FOCU-000554, FOCU-000555, FOCU-000556, FOCU-000557, FOCU-000558, FOCU-000562, FOCU-000565, FOCU-000566, FOCU-000567, FOCU-000568, FOCU-000569, FOCU-000570, FOCU-000571, FOCU-000572, FOCU-000573, FOCU-000574, FOCU-000575, FOCU-000576, FOCU-000577, FOCU-000578, focu-000579, focu-000580, FOCU-000581, FOCU-000582, FOCU-000583, FOCU-000584, FOCU-000585, FOCU-000586, FOCU-000587, FOCU-000588, FOCU-000589, FOCU-000590, FOCU-000591, FOCU-000592, FOCU-000593, FOCU-000594, FOCU-000595, FOCU-000596, FOCU-000597, FOCU-000598, FOCU-000599, FOCU-000600, FOCU-000601, FOCU-000602, FOCU-000603, FOCU-000604, FOCU-000605, FOCU-000606, FOCU-000607, FOCU-000608, FOCU-000609, FOCU-000610, FOCU-000611, FOCU-000612, FOCU-000613, FOCU-000614, FOCU-000615, FOCU-000616, FOCU-000617, FOCU-000618, FOCU-000619, FOCU-000620, FOCU-000621, FOCU-000622, FOCU-000623, focu-000624, FOCU-000625, focu-000626, FOCU-000627, FOCU-000628, FOCU-000629, FOCU-000630, FOCU-000631, FOCU-000632, FOCU-000633, FOCU-000634, FOCU-000635, FOCU-000636, FOCU-000637, FOCU-000638, FOCU-000639, FOCU-000640, FOCU-000641, FOCU-000642, FOCU-000643, FOCU-000644, focu-000645, focu-000646, FOCU-000647, focu-000648, focu-000649, FOCU-000650, FOCU-000651, FOCU-000652, FOCU-000653, FOCU-000654, FOCU-000655, FOCU-000656, FOCU-000657, FOCU-000658, FOCU-000659, FOCU-000660, FOCU-000661, FOCU-000662, FOCU-000663, FOCU-000664, FOCU-000665, FOCU-000666, FOCU-000667, FOCU-000668, FOCU-000669, FOCU-000670, FOCU-000671, FOCU-000672, FOCU-000673, FOCU-000674, FOCU-000675, FOCU-000676, FOCU-000677, FOCU-000678, FOCU-000679, FOCU-000680, focu-000681, focu-000682, focu-000683, focu-000684, focu-000685, focu-000686, focu-000687, focu-000688, focu-000689, focu-000690, FOCU-000691, FOCU-000692, FOCU-000693, FOCU-000694, FOCU-000695, FOCU-000696, focu-000697, FOCU-000698, FOCU-000699, FOCU-000700, FOCU-000701, FOCU-000702, FOCU-000703, FOCU-000704, FOCU-000705, FOCU-000706, FOCU-000707, FOCU-000708, FOCU-000709, FOCU-000710, FOCU-000711, FOCU-000712, FOCU-000713, FOCU-000714, FOCU-000715, FOCU-000716, FOCU-000717, FOCU-000718, FOCU-000719, F
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.