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U.S. Department of Health and Human Services

Class 2 Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM

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 Class 2 Recall
NAVIGATOR ANESTHESIA DELIVERY SYSTEM
see related information
Date Posted December 05, 2008
Recall Status1 Terminated on December 08, 2008
Recall Number Z-0319-2009
Recall Event ID 49713
Premarket Notification
510(K) Number
K080175 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product 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.
Code Information Serial Number: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number.
Recalling Firm/
Manufacturer
Mindray DS USA, Inc., dba Datascope Patient Monitoring
800 Macarthur Blvd
Mahwah, New Jersey 07430
For Additional Information Contact Thomas W. Barford
201-995-8391
Manufacturer 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
FDA Determined
Cause 2
DESIGN: 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 in Commerce 2 units
Distribution Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATASCOPE CORP., PATIENT MONITORING DIVISION
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