| Date Initiated by Firm | June 29, 2004 |
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| Date Posted | August 04, 2004 |
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| 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/
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. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| 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. |
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| 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.
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