Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand
FDA device recall Z-0182-2014 · posted 2013-11-08 · Terminated
Recall details
- Recalling firm
- Urologix, Inc.
- Reason for recall
- A Hand Piece high deployment force exceeded the maximum specification.
- Action taken
- Consignees were sent a Urologix Urgent Medical Device Recall letter dated October 21, 2013. The letter described the problem and the device involved in the recall. Advised consignees to examine their inventory and remove the recalled product. Requested consignees to complete and fax the "Customer Acknowledgement Form" to Hope Przybilla at 763-475-1443 or call her for questions. The consignees local representatives will be personally assisting them with the return process and ensuring that replacement product is offered and received promptly.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 142
- Distribution
- Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, KY, MA, MN, NC, NJ, NV, NY, OH, OR, TN, TX, and UT.
- Date initiated
- 2013-10-21
- Date posted
- 2013-11-08
- Date terminated
- 2014-04-21
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR (K113380) | Medtronic, Inc. | 2012-11-15 |