Recall Z-0291-2007 ยท BSZ Gas-Machine, Anesthesia
Datex - Ohmeda, Inc
Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411.
| Date | Dec 19, 2006 (initiated Sep 11, 2006) |
| Status | Terminated |
| Reason | Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia. |
| Root cause | Other |
| Action | All customers were contacted by letter in September 2006, and provided with a customer reply form. The firm sales some of the Compact Absorbers to distributors and they were asked to notify their Compact Absorber customers. Customers outside the US will be contacted to the end user and then their dealers and distributors. The letter said to immediately discontinue the use of all Compact Absorbers having a lot number as identified (reference codes 427002100 - white to violet color change) and (42700200 - pink to white color change). The affected lot numbers should be isolated and destroyed. |
| Quantity | 670,620 |
| Distribution | Worldwide, including USA, Austria, Australia, Belgium, Canada, Croatia, Germany, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Japan, South Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Unit |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973985 | AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) Datex-Engstrom, Inc., Oct 30, 1998 |