Z-1253-2025Class I

Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

Name: Z-1253-2025 Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Creator: Baxter Healthcare Corporation
Published: 2025-02-05
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-02-05 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX on 2025-02-05. FDA classified it as Class I and gives the reason as "There is the potential for missing motor mounting screws, which may have occurred during the servicing process". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1253-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-02-05
Posted: 2025-03-06
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Product code: FRN Pump, Infusion
Reason for recall: There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
FDA root cause: Under Investigation by firm
Action: Baxter issued an "URGENT MEDICAL DEVICE RECAL" notice to its consignees on 02/05/2025 via US Mail. The notice explained the issue, hazard involved, and requested the following actions be taken: "1. Immediately locate, isolate, and cease all use of Spectrum pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the infusion pump. 2. Contact Baxter to arrange for the return of the affected pumps for inspection and reservicing as applicable. 3. If you received this communication directly from Baxter, acknowledge receipt on the enclosed reply form even if you have no remaining inventory. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to all departments within your institution who use the affected product. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, or quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."
Quantity in commerce: 66 units
Distribution: US: Nationwide
Product codes and lots: UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453, 795240, 798065, 814485, 818850, 826637, 850214, 850854, 851500, 854157, 855803, 863354, 870307, 873114, 876483, 877014, 877102, 889153, 896292, 900181, 906422, 907176, 912242, 913562, 927864, 938265, 958176, 962828, 963975, 965158, 974676, 981605, 982459, 984154, 986132, 986634, 989053, 993087, 994417, 994842, 995538, 997153, 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1253-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1253-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-06
Z-1254-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)