Devices

Device Recall UROLOGIX CTC Advance" Standard Microwave Catheter

Model / Serial
KIT LOT NUMBER: ACP011610D, ACP011710E, ACP011810F, ACP011910G, AHP01810D, AHP011210A, AHP011310B, AHP012310C, AHP012510C, AHP012710C, ALP012510B, and RH00252 CATHETER LOT NUMBERS: 091226MCA1, 091228MHA1, 091229MCA1, 091229MCA2, 091229MHA1, 09123MCA1, 091230MHA1, 100105MHA1, 100106MHA1, 100106MHA2, 100111MHA1, 100111MHA2, 100111MHA3, 100112MLA2, 100113MHA1, 100113MHA2, and 100114MHA1 RTU PLUS LOT NUMBERS: Handle =RH00252, Balloon= RB0781 & RB0783
Product Classification
Gastroenterology-Urology Devices
Device Class
3
Implanted device?
No
Distribution
AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.
Product Description
UROLOGIX¿ CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manufactured by UROLOGIX¿, INC, 14405 Twenty-First Avenue North, Minneapolis, MN 55447. || The CTC Advance" catheters and RTU Plus are used as part of the Targis¿ System. || Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches.
Manufacturer
Urologix, Inc.
1 Event
- Recall of Device Recall UROLOGIX CTC Advance" Standard Microwave Catheter

Manufacturer

Urologix, Inc.

Manufacturer Address
Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
Source
USFDA

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