Recall Z-1239-04 ยท HQP Unit, Cautery, Thermal, Battery-Powered
Aaron Medical Industries, Inc.
Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip
| Date | Aug 4, 2004 (initiated Jun 29, 2004) |
| Status | Terminated |
| Reason | The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.