PSC Industries Recalls Button Switch Pen Electrodes Due to Labeling Errors
PSC Industries is recalling 50 units of Button Switch Pen Electrodes due to a labeling error where the manufacturer symbol replaced the expiration date symbol.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and labeling issue (incorrect symbol placement) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
PSC Industries Inc is recalling 50 units of Button Switch Pen Electrodes, Model Number 75820, Lot Number 019632. These single-use electrosurgical devices are used for coagulating and cutting tissue during surgical procedures. The recall is limited to units distributed nationwide, including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
The recall was initiated because the carton label for the device incorrectly displays the manufacturer symbol in the location where the expiration date symbol should be. Firm officials met with the FDA on May 17, 2012, to report various labeling errors associated with these products.
Healthcare facilities and distributors should stop using these specific units and contact PSC Industries for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- 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…
- Manufacturer
- PSC Industries Inc
- Hazard
- Affected units
- 50
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: 75820
- Lot Number: 019632
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.
See all 2 products in this recall →Related recalls
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