Z-0530-2022 Class I Ongoing
FDA device recall Z-0530-2022 was initiated by Baxter Healthcare Corporation on December 29, 2021 and is designated Class I. 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 incomp… The recall status is ongoing. Affected quantity: 146,502 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146,502 units
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.
Distribution Pattern
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.
Code Information
All serial numbers, GTIN 00085412498683.