United StatesThe affected product is the Tangent Endoscopy Tangent Single Use Digital Catheter (models TNG4002-IND and TNG-4007-6pk; UDI-DI 00850061601001) from lots 2510900, 2512938, and 2601944, distributed in the United States including North Carolina, Arizona, and Nevada (53 units). The firm recalled these catheters because they exhibited fractures at the distal shaft tip without complete detachment.
What's being recalled
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Recalling firm: Tangent Endoscopy, LLC, Camden, DE, United States.
How to identify it
(1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944. (2) Model Number: TNG-4007-6pk; UDI-DI: 00850061601001; Lot numbers: 2510900, 2512938, and 2601944
The hazard
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)