Z-1239-04
Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip
Apyx Medical Corporation / initiated 2004-06-29 / Terminated
Aaron Medical Industries, Inc. began a recall of Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip on . The reason FDA records is "The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1239-04
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Apyx Medical Corporation
- Product
- Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip
- Product code
- HQP Unit, Cautery, Thermal, Battery-Powered
- Reason for recall
- The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
- FDA 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 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.
- Product codes and lots
- 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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
