Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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