ClearanceBrief
Recall Z-1239-04 ยท HQP Unit, Cautery, Thermal, Battery-Powered

Aaron Medical Industries, Inc.

Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip

DateAug 4, 2004 (initiated Jun 29, 2004)
StatusTerminated
ReasonThe cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
Root causeOther
ActionEach 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.
Quantity154410
DistributionDistributed 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 recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.