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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1817-2022 |
| Event ID | 90809 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide Distribution and government/military distribution. |
| Quantity | 9,671 units |
| Recall Reason | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. |
| Device Classification | 20221005 |
| Device 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. |
| Center Classification Date | 20220926 |
| Recall Initiation Date | 20220902 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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