Device Recall Boston Scientific TSX Transseptal Needle 의 리콜

Recall

73630

Class 2

Z-1375-2016

2016-03-15

Terminated

United States

2016-08-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144636

Merit medical systems, inc. is voluntarily conducting a recall of one lot of the tsx" transseptal needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. the curve dimensional values on the labels of this lot incorrectly indicate a 50¿ curve, rather than the correct 86¿ curve.

The consignee was provided verbal and written notification of the field action on March 15, 2016. There was a total of one (1) consignee, an OEM customer in the USA, who received 25 units. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue distribution, and instructions to initiate a product recall in accordance with their company's established policies for customers to whom they shipped the affected Merit product. An email notification was sent to the Merit sales representative of the affected account. The sales representative was provided a Customer Response Form applicable to their account. The sales representative was instructed to assist the account with the completion of the Customer Response Form and the return of the affected units back to the Merit Field Assurance Department.