FDAClass IIAugust 19, 2015

AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001 recall

AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus…

Why was AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001 recalled?

AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

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?

161905

Product
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus…
Recalling firm
Boston Scientific Corporation
Quantity
total of 9 units
Distribution
Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
Recall date
August 19, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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