Recall Z-1817-2022 ยท DSB Plethysmograph, Impedance
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.
| Date | Sep 26, 2022 (initiated Sep 2, 2022) |
| Status | Open, Classified |
| Reason | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. |
| 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 w |
| Quantity | 9,671 units |
| Distribution | US Nationwide Distribution and government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083093 | CHEETAH RELIANT Cheetah Medical, Inc., Dec 15, 2008 |