FDAClass IIJuly 3, 2013

Terumo Glidesheath recall

Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.

Why was Terumo Glidesheath recalled?

Medical devices were incorrectly labeled with extended expiration dates.

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 MP08

Product
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
Recalling firm
Terumo Medical Corporation
Quantity
550 units
Distribution
Nationwide Distribution.
Recall date
July 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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