Recall Z-2066-2020— Baxter Healthcare Corporation

Name: FDA recall Z-2066-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-07

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-04-07, terminated 2021-11-09. It names one FDA 510(k) clearance: K131516. Product: Prismaflex Control Unit. Reason: Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Terminated: 2021-11-09
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K131516 — PRISMAFLEX SYSTEM 7.10Gambro Renal Products, Inc.·cleared 2014-01-03

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 Control Unit

Reason for recall

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

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