medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
FDA Recall Z-0198-2025 · Posted 2024-10-23
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusOpen, Classified
Product CodeDPT
Date Initiated2024-09-24
Product Quantity900 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.