Reported Oct 30, 2024 · Ongoing
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Smiths Medical ASD, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD, Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
- Lot codes and dates
UDI/DI 50351688503990 (case)10351688503992 (pouch)
- Lot Numbers
42776704287645428764942997764277696430893042998114308934429981243231484264943426493942776944264950429977943089624323175432851542997884299789429979042998014299802430895443089594308963432191743089474334499429978643557324355735434611542997804355730435572743345014346096434609743461244355733434610943557284355740435575043557494355746434612043557574355753
- Amount recalled
- 1160168 units
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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