Recall Z-0182-2025— Smiths Medical ASD, Inc.

Name: FDA recall Z-0182-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-24

Class II · Ongoing

Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2024-09-24. It names one FDA 510(k) clearance: K020780. Product: medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2. Reason: 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..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-24
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICPMedex, Inc.·cleared 2002-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.