Baxter Recalls Power Cords for AMIA Automated PD Cycler
Baxter Healthcare is recalling power cords for the AMIA Automated PD Cycler because the socket may detach when unplugged.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that could lead to injury or device failure, but no specific injuries or illnesses are reported in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Baxter Healthcare Corporation is recalling power cords for the AMIA Automated PD Cycler (Product Code: 5C9320) and the Kaguya PD System (Product Code: T5C8500). The recall involves 5,445 units distributed in the US and Japan. The Kaguya PD System is noted as being for Japanese distribution only.
The recall was initiated because 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. This defect could potentially compromise the integrity of the device's power connection.
Users of these devices should stop using the affected power cords and contact Baxter Healthcare Corporation for further instructions or a replacement. The recall number is Z-2597-2018.
The recalled product
- Product
- power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Power Cord
- Affected units
- 5,445
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
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