FDA-Device2022-10-05Class III
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.
Baxter Healthcare Corporation
Hazard
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Sold states
US Nationwide Distribution and government/military distribution.
Affected count
9,671 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1817-2022Don't want to check this manually?
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