FDANews
The QMN Weekly Bulletin

Mectra Warned for Touting New Needle Size on Website

Dec. 13, 2013
An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. The Bloomfield, Ind., company had clearance for 12 mm and 150 mm needles, but was also marketing a 75 mm needle, according to the Nov. 14 warning letter posted recently online.
Devices & Diagnostics Letter