FDA Recall
Terminated
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
Recall: Z-2532-2017
·
Initiated May 22, 2017
Recall
- Recall Number
- Z-2532-2017
- Event Number
- 77406
- Firm
- Creganna Medical Devices Parkmore West Galway Ireland
- FEI Number
- 3004193842
- Product Code
- DYB
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- May 22, 2017
- Terminated
- May 29, 2018
Description
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
Reason
Lack of sterility assurance.
Action
The firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled.
Distribution
Distributed in MA.
Quantity
50 units