Prostiva RF Therapy Hand Piece Kit recall
Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery…
Why was Prostiva RF Therapy Hand Piece Kit recalled?
A Hand Piece high deployment force exceeded the maximum specification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Kit Lot Number: 215251, Hand Piece Lot Number: 13E005M.
- Product
- Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery…
- Recalling firm
- Urologix, Inc.
- Quantity
- 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.
- Recall date
- November 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)