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.
Reported: October 5, 2022 Initiated: September 2, 2022 #Z-1817-2022
Product 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.
Reason for Recall
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 9,671 units
- Distribution
- US Nationwide Distribution and government/military distribution.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corporation. Units affected: 9,671 units.
Why was this product recalled? ▼
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Low. Recall number: Z-1817-2022.
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