TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Check your package for
(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
- Why
- Affected devices exhibited fractures at the distal shaft tip without complete detachment.
- Distributed
- US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
- Company
- TANGENT ENDOSCOPY, LLC
- Announced
- Recall began