Sterile recall
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in…
Why was Sterile recalled?
The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.
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?
Manufacturer's lot number: 54-12-2-21-12.
- Product
- Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in…
- Recalling firm
- Gynex Corporation
- Quantity
- 19 boxes (containing 12 electorde hand pieces each)
- Distribution
- Nationwide Distribution
- Recall date
- October 10, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)