Recall Z-0530-2022— Baxter Healthcare Corporation
Class I · Ongoing
Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-12-29. It names one FDA 510(k) clearance: K133801. Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.. Reason: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-12-29
- 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 with Master Drug Library (Version 8), Product code 35700BAX2.
Reason for recall
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
Data sourced from openFDA. This site is unofficial and independent of the FDA.