Device Recall Bovie Precise 360 Handpiece 의 리콜

Recall

74790

Class 2

Z-2646-2016

2016-07-18

Terminated

United States

2016-12-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148465

The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

Consignees were notified by written recall notice sent via certified mail or courier on July 18, 2016 to quarantine their inventory of the Precise 360 Handpiece, identify and contact their customers that have received the affected product and provide the a copy of the attached field safety notice. Customers are requested to return affected product, and return all affected product currently in their possession. All customer inventory should be reviewed, discontinue use, and return all Bovie Precise 360 handpieces to: Quality Assurance Department, Bovie Medical Corporation, 5115 Ulmerton Road, Clearwater, Florida 33760, Attn: Precise 360 Recall. Also, please write the authorization number RMA XXXX on the outside of the shipping container and use UPS account number 342562 and return via ground shipping and Fax or email the attached recall return response form to the email or fax indicated on the form as soon as possible and include a copy with the shipment. A completed recall return response form is required even if the customer has no product to return. If you have any questions about this recall or the product affected by the recall, call 727-803-8617.