Home » Mectra Warned for Touting New Needle Size on Website
Mectra Warned for Touting New Needle Size on Website
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
Devices Postmarket Safety Regulatory AffairsDevices & Diagnostics Letter
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