Recall Z-2531-2017 ยท DYB Introducer, Catheter
Creganna Medical Devices
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
| Date | May 22, 2017 |
| Status | Terminated |
| Reason | Lack of sterility assurance. |
| Root cause | Packaging |
| Action | The firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled. |
| Quantity | 100 uniits |
| Distribution | Distributed in MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131079 | CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC Creganna Medical Devices, Aug 1, 2013 |