Recall Z-1830-2020— Baxter Healthcare Corporation

Name: FDA recall Z-1830-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-06

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-02-06, terminated 2021-06-01. It names 2 FDA 510(k) clearances: K110823, K072093. Product: Prismaflex System, Prismaflex Control Unit. Reason: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-02-06
Terminated: 2021-06-01
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

2 on FDA's record

K110823 — PRISMAFLEXGambro Renal Products, Inc.·cleared 2011-06-17
K072093 — PRISMAFLEX SYSTEM, VERSION 3.20Gambro·cleared 2008-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Prismaflex System, Prismaflex Control Unit

Reason for recall

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.