The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. CTC Advance Standard , (3.0-5.0 cm), PT1036, Sterile EO,, Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. CTC Advance Long, (4.5+ cm), PT1038, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. Targis Standard, (3.0-5.0 cm), PT1013, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. The Urologix Targis system is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethral lengths greater than 2.5 cm.
This recall has been terminated (originally issued June 30, 2011).
- Company
- Urologix, Inc.
- Recall Initiated
- April 28, 2011
- Posted
- June 30, 2011
- Terminated
- April 26, 2012
- Recall Number
- Z-2710-2011
- Quantity
- 119
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Urologix is recalling certain lots of Targis System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure Kits containing a microwave catheter, a Coolant Bag and a RTU Plus balloon. The reason for this Recall involves three lots of Coolant Bags that contain an increased risk of leakage of water at the Sensor Module. This leak is detectabl
Distribution
Nationwide Distribution--including the states of AL, CA, CO, FL, GA, MA, MI, MN, NJ, NY, OR, PA, TN, WV, and including Puerto Rico.
Lot / Code Info
Catalog # / Lot No. PT1034 / AHP0333111A, AHP040411A, AHP040411B, AHP040611A, AHP040711A, AHP040811A, AHP041211A PT1036 / ACP033011B, ACP040111A, ACP040111B, ACP040611A, ACP040711A, ACP040711B, ACP040811A, ACP041211A PT1038 / ALP033111A, ALP040411A PT1013 / KP040711A CA1111B / C900284, C900285 and C900286 C900284, C900285 and C900286 C900284 and C900285 C900285
Root Cause
Nonconforming Material/Component
Action Taken
Urologix, Inc. sent an "IMPORTANT RECALL INFORMATION" letter dated April 28, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs the customers to identify the affected kit lots, remove the Coolant Bag pouch(s) and to complete and return a Return Material Authorization form with the product(s). Additionally, an enclosed Customer Acknowledgement Form should be completed and faxed to 763-475-1443. Customers with questions should contact the Director of Regulatory and Quality at 763-475-1400.