Recall Z-2597-2018
Baxter Healthcare Corporation · initiated July 12, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
Codes / lots: All Serial Numbers
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: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2597-2018
- Initiated
- July 12, 2018
- Terminated
- March 31, 2021
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 5445 units
- Distribution
- US and Japan
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL