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U.S. Department of Health and Human Services

Class 2 Device Recall DatexOhmeda Aestiva/5

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  Class 2 Device Recall DatexOhmeda Aestiva/5 see related information
Date Initiated by Firm April 16, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 14, 2005
Recall Number Z-0968-04
Recall Event ID 28936
510(K)Number K000706  
Product Classification Apparatus, Gas-Scavenging - Product Code CBN
Product Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.
Code Information Serial numbers AMVG01045, AMVG01047, AMVG01052, AMVG01062, AMVG01072 thru AMVG01083, AMVH00100 thru AMVH00109, AMVH00116, AMVH00125, AMVH00126, AMVH00129, AMVH00132, AMVH00133, AMVH00139, AMVH00141 thru AMVH00148, AMVH00151 thru AMVH00154, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00171 thru AMVH00186, AMVH00195 thru AMVH00198, AMVH00211, and AMVH00228 thru AMVH00230
Recalling Firm/
Manufacturer		 Datex-Ohmeda Inc
One Ohmeda Dr. Box 7550
Madison WI 53707
For Additional Information Contact Mr. Gary Muellenbach
800-345-2700 Ext. 3583
Manufacturer Reason
for Recall		 Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
FDA Determined
Cause 2		 Other
Action Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.
Quantity in Commerce 73 units
Distribution The affected units were distributed nationwide in the United States and worldwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBN and Original Applicant = DATEX-OHMEDA, INC.
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