Baxter Healthcare Corporation: Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMAB

Hazard

Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

Details from the source

Reason for recall: Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. Distribution: US Nationwide Distribution and government/military distribution. Quantity: 9,671 units Lot/code info: All serial numbers after 6/2016. Product code CMMST5 - Incorrect UDI-DI: 7290013030269; correct UDI-DI: 07290013030269. Product code CMM-ST5 - Incorrect UDI-DI: 7290013030030; correct UDI-DI: 07290013030030. Product code CMABATT - Incorrect UDI-DI: 7290013030160; correct UDI-DI: 07290013030160. Product code CMASC10 - Incorrect UDI-DI: 7290013030054; correct UDI-DI: 07290013030054.

UPC codes

7290013030269, 07290013030269, 7290013030030, 07290013030030, 7290013030160, 07290013030160, 7290013030054, 07290013030054

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.