CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report
Button Switchpens, w/Extendable Needle Electrode Exposure Single Use recalled
PSC Industries is recalling Button Switchpens, w/Extendable Needle Electrode Exposure Single Use, distributed nationwide in the US. The recall was initiated on 5 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1990-2012
- FDA event ID
- 62332
- Recalling firm
- PSC Industries, Louisville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2012
- FDA classified
- 11 Jul 2012
- Reported
- 18 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 5 Jun 2012 | Recall initiated by company | |
| 11 Jul 2012 | Classified by FDA | +36 days |
| 18 Jul 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Product as listed by the FDA
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 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.
Where it was distributed
Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
Nationwide CaliforniaDistrict of ColumbiaGeorgiaIndianaKentuckyLouisianaMontanaTexasUtahWisconsin
Questions about this recall
Is Button Switchpens, w/Extendable Needle Electrode Exposure Single Use recalled?
Yes. PSC Industries recalled Button Switchpens, w/Extendable Needle Electrode Exposure Single Use on 5 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-1990-2012.
Why was it recalled?
The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Which lots are affected?
Model Number: 75820, Lot Number: 019632
Where was it sold?
Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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