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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 DatexOhmedasee related information
Date Initiated by FirmFebruary 12, 2003
Date PostedApril 09, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall NumberZ-0714-03
Recall Event ID 25632
Product Classification Absorber, Carbon-Dioxide - Product Code BSF
ProductMulti Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)
Code Information Lot numbers 728112 and 798122 of the Multi Absorbers in the kits 
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
ActionRecall letters dated February 12, 2003 requested that the product be removed from use and returned.
Quantity in Commerce5 S/5 Aespire Start-up kits
DistributionNationwide in the United States.
Total Product Life CycleTPLC 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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