Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of 3.0-5.0 cm only. Model TA1121D.
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-0720-2007
- Quantity
- 96
- 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 numbers: M002671,M002672, M002589 and M002736 for model TA1121D. Kit box lot numbers: KP011206, KP053006B, KP053006C, KP060205, KP0011206.
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.
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