TANGENT ENDOSCOPY, LLC: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

Hazard

Affected devices exhibited fractures at the distal shaft tip without complete detachment.

Details from the source

Reason for recall: Affected devices exhibited fractures at the distal shaft tip without complete detachment. Distribution: US Nationwide distribution in the states of North Carolina, Arizona, and Nevada. Quantity: 53 units Lot/code info: (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

UPC codes

00850061601001

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.