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 |
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