PSC Industries Recalls Button Switchpens Due to Labeling Errors
PSC Industries is recalling Button Switchpens because the packaging labels incorrectly state the devices include a holster. The recall covers 725 units distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging and labeling discrepancy (missing holster) with no reported injuries, illnesses, or functional safety hazards.
Plain-English summary
PSC Industries Inc is recalling Button Switchpens with Extendable Needle Electrode 10 mm Exposure, Model Number 75800. The recall involves 725 units, specifically 125 units from Lot #023392 and 600 units from Lot #022438. These single-use electrosurgical devices are packaged in sterile Tyvek peel pouches within cardboard boxes.
The recall was initiated due to labeling errors. The Tyvek pouch labels for the device state 'with holster,' but the product does not actually include a holster. Firm officials met with the FDA on May 17, 2012, to report these various labeling errors.
The affected devices were distributed nationwide, including the District of Columbia and the states of California, Georgia, Indiana, Kentucky, Louisiana, Montana, Texas, Utah, and Wisconsin. Consumers and healthcare facilities should stop using these specific lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- PSC Industries Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number: 75800
- Lot Numbers: 023392 and 022438
Distribution
Part of a larger recall action
This product is one of 2 recalled by PSC Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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