Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for ...
FDA Recall #Z-1119-2021 — Class II — December 30, 2020
Product Description
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reason for Recall
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
385 devices
Distribution
Worldwide distribution.
Code Information
UDI 07332414007881, All lots within expiry
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated