FDAClass IIApril 10, 2019

Na¿da CL Q30 Sound Processor recall

Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

Why was Na¿da CL Q30 Sound Processor recalled?

The sound processors were loaded with the incorrect firmware.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Cl-5260-120 - Serial number 1047584, UDI (01)07630016838057(11)180309(21)1045784; Model Cl-5260-140 - Serial number 1047481, UDI (01)07630016829710(11)151208(21)1047481; and Serial number 1047482, UDI (01)07630016829710(11)151208(21)1047482; and Model Cl-5260-150 - Serial number 1082276, UDI (01)07630016838071(11)180925(21)1082276.

Product
Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Recalling firm
Advanced Bionics, LLC
Quantity
4 sound processors
Distribution
Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
Recall date
April 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls