Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Reported: April 5, 2023 Initiated: February 22, 2023 #Z-1316-2023
Product Description
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Reason for Recall
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 16 units
- Distribution
- US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.. Recalled by Baxter Healthcare Corporation. Units affected: 16 units.
Why was this product recalled? ▼
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2023. Severity: Moderate. Recall number: Z-1316-2023.
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