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.
FDA Recall Z-0319-2009 · Posted 2008-12-05
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Recalling FirmMindray DS USA, Inc., dba Datascope Patient Monitoring
Recall StatusTerminated
Product CodeBSZ
Date Initiated2008-10-07
Date Terminated2008-12-08
Product Quantity2 units
Reason for Recall
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
Firm Action
Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.
Root Cause
Component design/selection
Distribution Pattern
Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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