Smiths Medical recalls TranStar Kids Kit 7inch 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 7inch Blood Sample Kits with 30cc/hr Flush Devices because a manufacturing defect may cause inaccurate pressure readings or inability to zero the device. 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 providers using the TranStar Kids Kit 7inch Blood Sample Kit with 30cc/hr Flush Device for blood pressure monitoring in pediatric patients. Children receiving blood pressure measurements with this device are at risk of inaccurate readings.
Check for the product code REF MX9547 on the kit. The lot numbers 4223699, 4248326, 4297927, 4323137, 4340498, 4346068, or 4350022 are associated with this recall.
Review the product code and lot numbers listed in the recall notice to determine if your device is affected.
The recall is due to a manufacturing defect that may cause inaccurate pressure monitoring or inability to zero the device, potentially leading to incorrect blood pressure readings.
The recall notice does not specify a remedy, so check the product code and lot numbers to see if your device is affected.
The recall states the defect may cause inaccurate pressure monitoring, but does not mention a risk of serious injury or death.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0200-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0200-2025 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.
