Class 2 Device Recall medex TranStar

• Date Initiated by Firm: September 24, 2024
• Date Posted: October 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0190-2025
• Recall Event ID: 95438
• Product Classification: Probe, blood-flow, extravascular - Product Code DPT
• Product: medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
• Code Information: UDI/DI 50351688504041 (case), 10351688504043 (pouch), Lot Numbers: 4270150, 4277661, 4277716, 4287633
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: Mrs. Mary J. Ferreira; 845-907-1429
• Manufacturer Reason for Recall: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
• FDA Determined Cause: Process control
• Action: Smiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing. The notice explained the issue, potential risk, and requested the destruction of all affected product. Distributors were directed to forward the notice to their customers.
• Quantity in Commerce: 6590 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

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.