FDAClass IISeptember 14, 2016

Patient Cable recall

Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential…

Why was Patient Cable recalled?

Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.

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?

Part Number 4460: All Serial Numbers Part Number 6735: All Serial Numbers

Product
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential…
Recalling firm
Blackrock Microsystems, LLC
Quantity
120 total cables
Distribution
Worldwide Distribution - US Nationwide and Canada,
Recall date
September 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls