Recall Z-1719-2014
ConMed Corporation · initiated May 8, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Codes / lots: Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift).
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-1719-2014
- Initiated
- May 8, 2014
- Posted by FDA
- June 4, 2014
- Terminated
- April 11, 2017
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 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, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.
- Recalling firm
- ConMed Corporation, Utica, NY