Date Initiated by Firm |
June 29, 2004 |
Date Posted |
August 04, 2004 |
Recall Status1 |
Terminated 3 on May 03, 2012 |
Recall Number |
Z-1239-04 |
Recall Event ID |
29487 |
Product Classification |
Unit, Cautery, Thermal, Battery-Powered - Product Code HQP
|
Product |
Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip |
Code Information |
Sterile lot numbers: 0104E 0204B 0204C 0204E 0304A 0304C 0404A 0404C 0404H 0404J 0404G 0504A 0504F 0204A 0304E 0504B 0204D 0504D 0504C 0504E 0504F. EXP DATES 2/1/08-5/1/04 |
Recalling Firm/ Manufacturer |
Aaron Medical Industries, Inc. 7100 30th Ave N St Petersburg FL 33710-2902
|
For Additional Information Contact |
Vera MacElroy 727-803-8513
|
Manufacturer Reason for Recall |
The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
|
FDA Determined Cause 2 |
Other |
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 |
154410 |
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
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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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