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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 Cyclersee related information
Date Initiated by FirmJuly 12, 2018
Create DateAugust 02, 2018
Recall Status1 Terminated 3 on March 31, 2021
Recall NumberZ-2597-2018
Recall Event ID 80522
510(K)NumberK151525 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Productpower 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 ContactCenter 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
ActionMethod 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 Commerce5445 units
DistributionUS and Japan
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FKX
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