FDA Device recall Z-1817-2022
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products)
- FDA Device
- Class III
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class III recall of Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products) by Baxter Healthcare, citing labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1817-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-09-02 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
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.
Reason
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Identifiers
| code_info | All serial numbers after 6/2016. Product code CMMST5 - Incorrect UDI-DI: 7290013030269; correct UDI-DI: 07290013030269…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1817-2022%22
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