FDA Recall
Open, Classified
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Recall: Z-2530-2024
·
Initiated June 14, 2024
Recall
- Recall Number
- Z-2530-2024
- Event Number
- 94959
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 14, 2024
- Posted
- August 7, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Reason
Improperly performed testing prior to release
Action
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.
Distribution
US Nationwide distribution in the state of Florida.
Quantity
1 unit