Baxter Healthcare Corporation Recall 89017
Description: Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Baxter Healthcare Corporation Recall 89017 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0529-2022 |
Event ID | 89017 |
Event Description | Baxter Spectrum IQ Infusion Pumps, Product code 3570009. |
Product Type | Devices |
Distribution | Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago. |
Quantity | 175,028 units |
Recall 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. |
Device Classification | 20220209 |
Device Code Info | All serial numbers, GTIN 00085412610900. |
Center Classification Date | 20220128 |
Recall Initiation Date | 20211229 |
Recalling Firm | Baxter Healthcare Corporation |
Initial Notification | Letter |
Similar To |