Z-1123-2021 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
February 24, 2021
Initiation Date
December 30, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25785 devices

Product Description

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - 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.

Distribution Pattern

Worldwide distribution.

Code Information

UDI 07332414112400, All lots within expiry