Recall Z-0319-2009 ยท BSZ Gas-Machine, Anesthesia
Mindray DS USA, Inc., dba Datascope Patient Monitoring
AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
| Date | Dec 5, 2008 (initiated Oct 7, 2008) |
| Status | Terminated |
| Reason | Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate |
| Root cause | Component design/selection |
| Action | Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery. |
| Quantity | 2 units |
| Distribution | Only 2 units are in distribution, both in the same facility in Redondo Beach, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080175 | NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 Datascope Corp., Patient Monitoring Division, Jun 9, 2008 |