Health product recall

Sigma Spectrum, Wireless Battery Module (2021-01-12)

Starting date:
January 12, 2021
Posting date:
January 29, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74875

Last updated: 2021-02-22

Affected Products 

Sigma Spectrum, Wireless Battery Module

Reason

Baxter Corporation is issuing an urgent medical device correction to the user level for all Spectrum battery modules, due to customer reports of battery performance issues related to prolonged storage without recharging the battery. The affected battery modules are used with all versions of Spectrum infusion pumps.

Affected products

Sigma Spectrum, Wireless Battery Module

Lot or serial number

All serial numbers. 

Model or catalog number

35162
35195
35724

Companies
Manufacturer
Baxter Healthcare Corporation
711 Park Ave.
Medina
14103
New York
UNITED STATES