FDAClass IIJuly 29, 2020

Accurian RF Ablation recall

Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile…

Why was Accurian RF Ablation recalled?

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

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?

Lot # BY19L007 BY19M013 BY20A014 BY20C011

Product
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile…
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
778 pk
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Recall date
July 29, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls