FDAClass IIMarch 7, 2018

Destination Guiding Sheath catheter introducer recall

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the…

Why was Destination Guiding Sheath catheter introducer recalled?

The tucking depth feature of this catheter introducer is marginally outside the upper specification.

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: VK09, Expiration Date: 31-Jan-2020

Product
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the…
Recalling firm
Terumo Medical Corporation
Quantity
33
Distribution
To be added.
Recall date
March 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls