PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 21, 2017 Initiated: May 22, 2017 #Z-2531-2017

Product Description

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

Reason for Recall

Lack of sterility assurance.

Details

Recalling Firm
Creganna Medical Devices
Units Affected
100 uniits
Distribution
Distributed in MA.
Location
Galway, N/A

Frequently Asked Questions

What product was recalled?
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400. Recalled by Creganna Medical Devices. Units affected: 100 uniits.
Why was this product recalled?
Lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2531-2017.