FDA MedWatch Class 2 Device Recall: AMIA Automated PD Cycler

Date Initiated by Firm

July 12, 2018

Create Date

August 02, 2018

Recall Status1

Open3, Classified

Recall Number

Z-2597-2018

Recall Event ID

8052223

510(K)Number

K15152524  

Product Classification

System, peritoneal, automatic delivery25 - Product Code FKX26

Product

Power cord for: (a) AMIA Automated PD

Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500

(Japanese distribution only)

Code Information

All Serial Numbers

Recalling Firm/
Manufacturer

Baxter Healthcare Corporation
1 Baxter

Pkwy
Deerfield IL 60015-4625

For Additional Information Contact

Center for One Baxter
800-422-9837

Manufacturer 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.

FDA Determined
Cause 2

Under Investigation by firm

Action

Method of Notification: A Safety Alert communication will be sent to affected customers via U.S.P.S., first class mail. Mitigating Instructions: Baxter is asking customers to: 1. Unplug the devices from the wall before unplugging the power cord from the back of the cycler. 2. Confirm the receipt of the letter by completing the enclosed customer reply form and returning it to Baxter by either mail, fax, or scanned email.

Quantity in Commerce

5445 units

Distribution

US and Japan

Total Product Life Cycle

TPLC Device Report27

 

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls28.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

510(K) Database

510(K)s with Product Code = FKX and Original Applicant = DEKA RESEARCH AND DEVELOPMENT29