Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D.
This recall has been terminated (originally issued April 5, 2007).
- Company
- Urologix, Inc.
- Recall Initiated
- March 16, 2007
- Posted
- April 5, 2007
- Terminated
- May 25, 2007
- Recall Number
- Z-0721-2007
- Quantity
- 21
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
Distribution
Nationwide and the Netherlands.
Lot / Code Info
Individual catheter lot number KG001346 for model TA1321D. Kit box lot number KGP111105.
Root Cause
Other
Action Taken
A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.
More recalls by Urologix, Inc.
Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide.
The Prostiv...
Nov 8, 2013
The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOG...
Jun 30, 2011
UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter...
Mar 19, 2010