Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
FDA device recall Z-1316-2023 · posted 2023-04-01 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- The electrical safety testing was not properly performed on the impacted devices and additional testing is required
- Action taken
- Baxter notified consignees via phone call on 02/22/2023. The notification outlined the issue and that Baxter was retrieving the units and then replacing them within 24 hours.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- FKX
- Quantity affected
- 16 units
- Distribution
- US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
- Date initiated
- 2023-02-22
- Date posted
- 2023-04-01
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (K201867) | Baxter Healthcare Corporation | 2020-11-19 |