Datascope Corporation Recall 90684
Description: MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Datascope Corporation Recall 90684 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1685-2022 |
| Event ID | 90684 |
| Event Description | MEGA 8Fr 50cc Intra-Aortic Balloon Catheter |
| Product Type | Devices |
| Distribution | Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom. |
| Quantity | 10,427 units |
| Recall Reason | Certain lots containing undersized dilator. |
| Device Classification | 20220914 |
| Device Code Info | Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01. |
| Center Classification Date | 20220908 |
| Recall Initiation Date | 20220805 |
| Recalling Firm | Datascope Corporation |
| Initial Notification | Letter |
| Similar To |