Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0204-2025 — medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260

U.S. FDA — Device Enforcement · United States · 2024-09-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0204-2025
Date of alert
2024-09-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smiths Medical ASD, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50351688518833
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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