Smiths Medical recalls TranStar Kids Kit 19in Blood Sample Kit with 30cc/hr Flush Device due to potential inaccurate pressure monitoring from a manufacturing defect in the pressure transducer.
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.
Smiths Medical is recalling TranStar Kids Kit 19in Blood Sample Kits with 30cc/hr Flush Devices because a manufacturing defect may cause inaccurate pressure readings or device failure. This could lead to incorrect blood pressure monitoring in medical settings.
The device may have a leak or defect in the pressure transducer chip, causing inaccurate pressure monitoring. This could lead to incorrect blood pressure readings during medical procedures, potentially affecting patient care decisions.
Healthcare professionals using the TranStar Kids Kit 19in Blood Sample Kit with 30cc/hr Flush Device for pediatric blood pressure monitoring are most at risk. Patients receiving this device for blood pressure checks may experience inaccurate readings.
Check for the product code REF MX9543 on the kit. The lot numbers 4297925, 4340497, and 4355387 are associated with this recall. The kit includes 10 units per case.
Inspect the pressure transducer for signs of leakage or damage before use.
Reach out to Smiths Medical for guidance on device safety and potential remedies.
This recall affects medical devices used for pediatric blood pressure monitoring. If you use the TranStar Kids Kit 19in Blood Sample Kit with 30cc/hr Flush Device, check for the product code REF MX9543 and lot numbers listed in the recall.
Look for the product code REF MX9543 on the kit. The lot numbers 4297925, 4340497, and 4355387 are associated with this recall. The kit includes 10 units per case.
The recall does not specify a return or replacement process. Contact Smiths Medical directly for guidance on device safety and potential remedies.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0197-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0197-2025 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
