Z-2529-2017 Class II Terminated
FDA device recall Z-2529-2017 was initiated by Creganna Medical Devices on May 22, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated May 29, 2018). Affected quantity: 85 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 22, 2017
- Termination Date
- May 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units
Product Description
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Distributed in MA.
Code Information
Lot # 364951, 385149