Angiodynamics, Inc. Recall 90924
Description: Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling UPN: H787MPP5SAT0 Catalog Number: MP-P5SAT
Angiodynamics, Inc. Recall 90924 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0132-2023 |
| Event ID | 90924 |
| Event Description | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling UPN: H787MPP5SAT0 Catalog Number: MP-P5SAT |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, DC, IN, PA. |
| Quantity | 11 units |
| Recall Reason | Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury. |
| Device Classification | 20221102 |
| Device Code Info | UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025 |
| Center Classification Date | 20221025 |
| Recall Initiation Date | 20220920 |
| Recalling Firm | Angiodynamics, Inc. |
| Initial Notification | Letter |
| Similar To |