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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 29, 2004
Date Posted August 04, 2004
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-1238-04
Recall Event ID 29487
Product Classification Unit, Cautery, Thermal, Battery-Powered - Product Code HQP
Product Battery-operated Cautery
Low Temperature, fine/elongated Tip
Code Information Sterile lot numbers: 0204B 0204D 0204E 0304A 0304C 0304D 0404A 0404E 0404G 0404H 0404J 0504A 0504C 0504E 0504F. EXP DATES 2/1/08-5/1/04
Recalling Firm/
Aaron Medical Industries, Inc.
7100 30th Ave N
St Petersburg FL 33710-2902
For Additional Information Contact Vera MacElroy
Manufacturer Reason
for Recall
The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
FDA Determined
Cause 2
Action Each consignee will be notified by letter of the recall with instruction for the disposal of the product determined to be hazardous. Each letter will have a questionnaire attached with a 800 fax number for replying to the firm.
Quantity in Commerce 16700
Distribution Distributed to: 291 accounts in the USA, 8 in Canada, 18 in Europe, 1 in the Middle East, 1 in Asia, 4 in the Pacific Rim 1 in Africa and 5 US goverment/Military.
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.