Z-0530-2022Class I

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2

Name: Z-0530-2022 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2
Creator: Baxter Healthcare Corporation
Published: 2021-12-29
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-12-29 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2 on 2021-12-29. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0530-2022
Classification: Class I
Status: Open, Classified
Initiated: 2021-12-29
Posted: 2022-01-29
Recalling firm: Baxter Healthcare Corporation
Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent URGENT SAFETY COMMUNICATION letters on 12/29/2021 via first class mail, addressed to Directors of Biomedical Engineering, Risk Management, Nursing, and Nurse Educators. The letter described the problem, the affected product (Spectrum V8 and Spectrum IQ infusion pumps), hazard involved, and the actions to be taken by customers. Acknowledge receipt on customer portal https://BaxterFieldActionCustomerPortal.onprocess.com/. Follow on-screen instructions, infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections, and upstream occlusion alarm troubleshooting in the Alarms section of the Operator's Manual. Upon an upstream occlusion alarm, do not press the RUN/STOP key prior to inspecting the IV tubing and resolving any occlusions. If an upstream occlusion remains after the RUN/STOP key is pressed, the pump may appear to be infusing normally, and may be infusing below the programmed rate or not at all. If you may have resumed an infusion without clearing an occlusion, stop the infusion: press the RUN/STOP key, clear the occlusion, and restart the infusion. Per the IFU: It is important to completely spike the IV container, remove the blue slide clamp completely from the keyhole, disengage the blue slide clamp completely from the IV tubing, check that the IV tubing is clear of any kinks or collapsed sections, ensure the roller clamp is released prior to infusion start, and ensure that rigid and semirigid containers are properly vented. After starting the infusion, verify that drips are flowing in the drip chamber. If an upstream occlusion is not fully cleared above the pump and/or within the pumping channel, an upstream occlusion alarm may not reoccur. **On 1/19/2022, the firm reported they plan to issue a follow-up communication approximately March 2022 to customers once the IFU has been updated and will include information regarding upcoming software updates. The firm sent a follow-up URGENT DEVICE CORRECT
Quantity in commerce: 146,502 units
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.
Product codes and lots: All serial numbers, GTIN 00085412498683.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0530-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0529-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0530-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-02-09	2022-01-28

Product code FRN

K133801Class IIBaxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation / cleared 2014-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)