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Starling Monitor, Product code CMMST5 and Starling Monitor… recallZ-1817-2022 · Baxter Healthcare Corporation · initiated Sep 2, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1817-2022
Status
Open, Classified
Initiated by the company
Sep 2, 2022
Posted by the FDA
Sep 26, 2022
Recalling firm
Baxter Healthcare Corporation
Quantity
9,671 units
Product code
DSB
FDA submissions
K083093
Distribution
US Nationwide Distribution and government/military distribution.

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.

Code information (models, lots, serial 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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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