Device product
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Z-2531-2017
Product summary
- Event
- Event 77406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 uniits
- Official record key
device-enforcement:Z-2531-2017
Official wording
Reason: Lack of sterility assurance.
Code information: Lot # 363848
Distribution pattern: Distributed in MA.
Derived failure modes
-
Sterility assurance
Lack of sterility