Date Initiated by Firm |
February 12, 2003 |
Date Posted |
April 09, 2003 |
Recall Status1 |
Terminated 3 on July 02, 2004 |
Recall Number |
Z-0714-03 |
Recall Event ID |
25632 |
Product Classification |
Absorber, Carbon-Dioxide - Product Code BSF
|
Product |
Multi 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 |
Action |
Recall letters dated February 12, 2003 requested that the product be removed from use and returned. |
Quantity in Commerce |
5 S/5 Aespire Start-up kits |
Distribution |
Nationwide in the United States. |
Total Product Life Cycle |
TPLC Device Report
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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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