Date Initiated by Firm |
September 02, 2022 |
Date Posted |
September 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1817-2022 |
Recall Event ID |
90809 |
510(K)Number |
K083093
|
Product Classification |
Plethysmograph, impedance - Product Code DSB
|
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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
|
For Additional Information Contact |
Center for One Baxter 800-422-9837
|
Manufacturer Reason for Recall |
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = DSB and Original Applicant = CHEETAH MEDICAL INC.
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