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U.S. Department of Health and Human Services

Class 3 Device Recall AEROSET

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  Class 3 Device Recall AEROSET see related information
Date Initiated by Firm January 27, 2003
Date Posted May 09, 2003
Recall Status1 Terminated 3 on April 07, 2004
Recall Number Z-0796-03
Recall Event ID 25701
510(K)Number K980367  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product AEROSET System External Waste Pump
Code Information Product List Number 9D61-01, no lot numbers or codes
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 2020
Irving TX 75038
Manufacturer Reason
for Recall
External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
FDA Determined
Cause 2
Action Firm sent 01/27/2003 letter to all consingees informing them of the issue. US Cutomer Reply form will be distributed with the customer letter.
Quantity in Commerce 461 units
Distribution Nationwide and to the following foreign countries: Mexico, Chilie, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zealand, Malaysia, Japan, Taiwan, Korea, Singapore, Thailand
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 = JJE and Original Applicant = ABBOTT LABORATORIES