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U.S. Department of Health and Human Services

Class 2 Device Recall DatexOhmeda

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  Class 2 Device Recall DatexOhmeda see related information
Date Initiated by Firm February 12, 2003
Date Posted April 09, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-0713-03
Recall Event ID 25632
Product Classification Absorber, Carbon-Dioxide - Product Code BSF
Product Multi Absorbers, reference number 8003138
Code Information Lot numbers 728112 and 798122
Recalling Firm/
Manufacturer		 Datex-Ohmeda
3030 Ohmeda Dr. Box 7550
Madison WI 53707
Manufacturer Reason
for Recall		 Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
FDA Determined
Cause 2		 Other
Action Recall letters dated February 12, 2003 requested that the product be removed from use and returned.
Quantity in Commerce 167 cases (6 Multi Absorbers per case)
Distribution Nationwide in the United States.
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.
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