FDA Device recall Z-1991-2012
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Mo…
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Mo… by Psc Industries, citing the Tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they rep….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1991-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-05 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Psc Industries |
| Distribution | US |
Product
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
Reason
The Tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors with their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Identifiers
| code_info | Model Number: 75800, Lot Numbers: 023392 and 022438 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1991-2012%22
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