Recall Z-2597-2018— Baxter Healthcare Corporation

Name: FDA recall Z-2597-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-12

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2018-07-12, terminated 2021-03-31. It names one FDA 510(k) clearance: K151525. Product: power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only). Reason: There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-07-12
Terminated: 2021-03-31
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K151525 — Amia Automated PD System with SharesourceDeka Research and Development·cleared 2015-10-09

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

power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)

Reason for recall

There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket.

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