FDAClass IIOctober 9, 2013

NC Sprinter recall

NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway…

Why was NC Sprinter recalled?

Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.

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 number 207002011; Exp 5-13-2015.

Product
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway…
Recalling firm
Medtronic Vascular, Inc.
Quantity
122
Distribution
Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.
Recall date
October 9, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls