Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System 의 리콜

Recall

76603

Class 2

Z-1512-2017

2017-02-28

2017-03-08

Terminated

United States

2017-08-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153632

The device did not have revolve stereo probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.

Devicor sent an Urgent Medical Device Recall letter dated March 10, 2017 to all affected consignees via first class mail. The recall response rate will be tracked and reconciled by consignee's response form, certifications of product inventory, and/or disposal. Consignees were asked to complete and return the enclosed response form as soon as possible. Consignees with any questions were instructed to call Mammotome Customer Service at 1-877-926-2666. For questions regarding this recall call 513-864-9158.