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Baxter Healthcare Corporation Recall 90809

Description: 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 Recall 90809 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1817-2022
Event ID90809
Event DescriptionStarling 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.
Product TypeDevices
DistributionUS Nationwide Distribution and included government/military distribution.
Quantity9,671 units
Recall ReasonLabeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Device Classification20221005
Device Code InfoAll 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.
Center Classification Date20220926
Recall Initiation Date20220902
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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