Z-1817-2022Class III

Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and...

Name: Z-1817-2022 Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and...
Creator: Baxter Healthcare Corporation
Published: 2022-09-02
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-09-02 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product... on 2022-09-02. FDA classified it as Class III and gives the reason as "Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1817-2022
Classification: Class III
Status: Open, Classified
Initiated: 2022-09-02
Posted: 2022-09-26
Recalling firm: Baxter Healthcare Corporation
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.
Product code: DSB Plethysmograph, Impedance
Reason for recall: Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 9,671 units
Distribution: US Nationwide Distribution and government/military distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1817-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1817-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-26

Product code DSB

K083093Class IICheetah ReliantCheetah Medical, Inc. / cleared 2008-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)