Baxter Healthcare Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Baxter Healthcare Corporation is recalling Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); due to Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Recommended Action
Per FDA guidance
The firm issued MEDICAL DEVICE CORRECTION letters dated 9/2/2022 via first class mail on 9/2/2022. The letter described the problem, the affected product, as well as listing the incorrect UDI number and the correct UDI number, the hazard involved, and the actions to be taken by the customers. The actions were: (1) The customer can continue to safely use the Starling products listed per the Starling Monitor's Instructions for Use (IFU); (2) Baxter will contact the facility to arrange for Baxter representative to relabel Starling Monitors and any packaged Starling accessories and spare parts when the updated labeling is available. Enclosed with the letter was an attachment showing examples of UDI labeling. A Reply Form Instruction Sheet was also enclosed. If you have any questions, call Center for One Baxter at 800-422-9837 or Commercial number: 847-948-4770. Baxter updated their correction strategy on 1/10/2023. When Baxter contacts customers to arrange for the replacement of the labeling on their Starling Monitors, customers will also be asked if they have any packaged accessories and spare parts. At that time, Baxter will offer the option for product replacement or notify the customer that since the contents of the packages do not contain the impacted labeling, they may discard the outer packaging and use the accessories and spare parts as intended.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026