Z-2597-2018 Class II Terminated
FDA device recall Z-2597-2018 was initiated by Baxter Healthcare Corporation on Jul 12, 2018 and is designated Class II. 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. The recall status is terminated (terminated Mar 31, 2021). Affected quantity: 5445 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- Jul 12, 2018
- Termination Date
- Mar 31, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5445 units
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.
Distribution Pattern
US and Japan
Code Information
All Serial Numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2597-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026