Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils,

FDA device recall Z-1991-2012 · posted 2012-07-11 · Terminated

Recall details

Recalling firm

PSC Industries Inc

Reason for recall

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.

Action taken

Olsen Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated June 5, 2012. The letter identifies the product, problem, and actions to be taken by the customers. The letter asks that the customer immediately examine their inventory for the presence of the suspect product and quarantine the product, if found. Customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall. The customers are also asked to call a toll-free telephone number in order to received a Return Material Authorization (RMA) number and so identify if they would like credit or replacement inventory upon returning the product. The customer is also asked to complete and return the enclosed 'Recall Response Form' and to fax the completed form to the fax number on the form or to send the completed from back to the recalling firm via parcel post.

Root cause

Labeling mix-ups

Status

Terminated

Product code

GEI

Quantity affected

725 units (125=Lot #023392 & 600 units Lot #022438)

Distribution

Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.

Date initiated

2012-06-05

Date posted

2012-07-11

Date terminated

2014-01-17

Location

Louisville, KY

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