Z-0672-2017Class II

V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA...

Name: Z-0672-2017 V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA...
Creator: Baxter Healthcare Corp.
Published: 2016-09-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2016-09-28 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a... on 2016-09-28. FDA classified it as Class II and gives the reason as "A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0672-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-28
Posted: 2016-11-29
Terminated: 2018-06-15
Recalling firm: Baxter Healthcare Corporation
Product: V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.
Product code: FRN Pump, Infusion
Reason for recall: A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter sent an Urgent Medical Device Correction letter dated September 28, 2016, to all affected customers. On 10/27/2016, Baxter Healthcare sent a f/u UMDC Letter (dated 10/27/2016) to customers. The f/u letter contains the device correction plan which states that Baxter will be replacing at no charge the rear case assembly on all affected Sigma Spectrum Infusion Pumps, as well as affected stand-alone rear case assemblies shipped to customers as spare parts. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.
Quantity in commerce: 439 units
Distribution: Nationwide Distribution, Puerto Rico and Canada
Product codes and lots: Product Code 35701; distributed between 02/04/2015 - 06/02/2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0672-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0670-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-29
Z-0671-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-29
Z-0672-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-29

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)