FDA recall Z-2532-2017
Creganna Medical Devices · Class II · device
Product
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
Reason for recall
Lack of sterility assurance.
Distribution
Distributed in MA.
Key facts
- Status
- Terminated
- Initiation date
- 2017-05-22
- Report date
- 2017-06-21
- Termination date
- 2018-05-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Galway, N/A, Ireland
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2532-2017