Recall Z-2530-2024— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-06-14. It names one FDA 510(k) clearance: K230022. Product: Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2. Reason: Improperly performed testing prior to release.
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-14
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Reason for recall
Improperly performed testing prior to release
Data sourced from openFDA. This site is unofficial and independent of the FDA.