Z-0132-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2022
- Initiation Date
- September 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product 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
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, DC, IN, PA.
Code Information
UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025