Conavi Medical Inc.: Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter De

Hazard

Due to manufacturing issues there is a potential for the catheter sheath to detach.

Details from the source

Reason for recall: Due to manufacturing issues there is a potential for the catheter sheath to detach. Distribution: US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China Quantity: 685 Lot/code info: Model No: TA-06-0001 UDI-DI: (01)00628055603054 Lot number: 230902; Expiration date: 2024-06; Lot number: 240202; Expiration date: 2025-03; Lot number: 240302; Expiration date: 2025-04; Lot number: 240402; Expiration date: 2025-05; Lot number: 240502; Expiration date: 2025-06; and all catheter lots which were expired (See attachment 2a, 2b and 2c for details).

UPC codes

00628055603054

Source

Official record: FDA (Device enforcement) ↗

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