—#195922

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.

FDA product code: DSB — Plethysmograph, Impedance
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K083093
Affected lot / 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.

Why it was recalled

Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide Distribution and government/military distribution.

Timeline

Recall initiated: 2022-09-02
Posted by FDA: 2022-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195922. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.