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
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