Reported Jul 18, 2012 · Terminated
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable…
PSC Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PSC Industries Inc · 3230 Commerce Center Pl · Louisville, KY · 40211-1900
Is this the product you have?
- Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304
- Model Number75800. 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
- Lot codes and dates
- Model Number75800
- Lot Numbers023392 and 022438
- Amount recalled
- 725 units (125=Lot #023392 & 600 units Lot #022438)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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