Starling Monitor recall: Labeling Error
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery…
Why was Starling Monitor recalled?
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 9,671 units
- Distribution
- US Nationwide Distribution and government/military distribution.
- Recall date
- October 5, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)