Cook Incorporated Recall 95405
Description: Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
Cook Incorporated Recall 95405 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0045-2025 |
| Event ID | 95405 |
| Event Description | Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve. |
| Product Type | Devices |
| Distribution | International distribution to the country of Australia. |
| Quantity | 50 units |
| Recall Reason | Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect. |
| Device Classification | 20241016 |
| Device Code Info | UDI-DI: 00827002272422; Lot Number: 15506769 |
| Center Classification Date | 20241009 |
| Recall Initiation Date | 20240916 |
| Recalling Firm | Cook Incorporated |
| Initial Notification | Letter |
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