SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA device recall Z-1121-2026 · posted 2026-01-16 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.

Action taken

An URGENT MEDICAL DEVICE RECALL notification letter dated 11/28/25 was sent to customers. Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of the impacted product (see Attachment A for complete list of affected serial numbers). The product code and serial number can be found on the bottom of the infusion pump. 2. If you received this communication directly from Baxter, please acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 3. If you purchased this product from a distributor or wholesaler, please contact them to arrange for return of the affected product. Please note that responding to Baxter is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the director of nursing, director of pharmacy, director of purchasing, facility risk manager, chief of medicine, medical director, office manager, and any other departments within your institution who use the affected product. 5. 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 if you experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 (select option 1, then option 2) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

FRN

Quantity affected

585 units

Distribution

US Nationwide distribution.

Date initiated

2025-11-28

Date posted

2026-01-16

Location

Deerfield, IL

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