FDAClass IIJune 21, 2017

Boston Scientific Zurpaz(TM) MEDIUM CURL recall: Sterility Concern

Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400

Why was Boston Scientific Zurpaz(TM) MEDIUM CURL recalled?

Lack of sterility assurance.

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 # 363848

Product
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Recalling firm
Creganna Medical Devices
Quantity
100 uniits
Distribution
Distributed in MA.
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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