Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of 3.0-5.0 cm only. Model TA1121D.
FDA device recall Z-0720-2007 · posted 2007-04-05 · Terminated
Recall details
- Recalling firm
- Urologix, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEQ
- Quantity affected
- 96
- Distribution
- Nationwide and the Netherlands.
- Date initiated
- 2007-03-16
- Date posted
- 2007-04-05
- Date terminated
- 2007-05-25
- Location
- Minneapolis, MN
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