FDAClass IIFebruary 17, 2016

2.3mm Turbo-Power OTW recall

2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device…

Why was 2.3mm Turbo-Power OTW recalled?

The product is labeled with an expiration date that is past its shelf life.

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 CMP15J28A

Product
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device…
Recalling firm
Spectranetics Corp.
Quantity
8 units
Distribution
Nationwide distribution to Florida, North Carolina and Pennsylvania.
Recall date
February 17, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls