MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during ele

FDA device recall Z-1719-2014 · posted 2014-06-04 · Terminated

Recall details

Recalling firm

ConMed Corporation

Reason for recall

ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.

Action taken

ConMed sent an Urgent Medical Device Recall letter dated May 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Corrective Action: All returned devices will be received into the facility and the lot number and quantity recorded on to an electronic spreadsheet. The returned product will then be stored in a secure quarantined area. At this time, management has not determined as to how the devices will be dispositioned. A protocol(s) will be written to address the destruction of the returned devices. This will be submitted to NYK-DO for approval prior to any action being taken with the returned devices. CAPA 153136 was opened. Fixtures were revised to allow for placement of the foil/gel substrate from the bottom of the foam. This is to maintain consistent dimensions on the product and not allow for float/movement of the substrate from being offset. For further questions please call (315) 624-3024 or fax to (315) 624-3030.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GEI

Quantity affected

Domestic - 12,600 units, Foreign - 44,280 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japa

Date initiated

2014-05-08

Date posted

2014-06-04

Date terminated

2017-04-11

Location

Utica, NY

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