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U.S. Department of Health and Human Services

Class 2 Device Recall AMIA Automated PD Cycler

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  Class 2 Device Recall AMIA Automated PD Cycler see related information
Date Initiated by Firm July 12, 2018
Create Date August 02, 2018
Recall Status1 Open3, Classified
Recall Number Z-2597-2018
Recall Event ID 80522
510(K)Number K151525  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
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 Report

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 recalls.
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 DEVELOPMENT
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