Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
FDA device recall Z-2530-2024 · posted 2024-08-07 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Improperly performed testing prior to release
- Action taken
- The impacted customer was contacted via phone call on 6/14/2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter to be serviced.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of Florida.
- Date initiated
- 2024-06-14
- Date posted
- 2024-08-07
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (K230022) | Baxter Healthcare Corporation | 2023-03-31 |