FDA-Device2017-06-21Class II

Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200

Creganna Medical Devices
Hazard

Lack of sterility assurance.

Sold states
Distributed in MA.
Affected count
85 units
Manufactured in
Parkmore West, N/A, Galway, N/A, Ireland
Products
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2529-2017

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