Smiths Medical recalls LogiCal Left Heart Kit Model M20553 with insufficient welds in specific lots. These components may cause leaks or failures during blood pressure monitoring.
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
Smiths Medical is recalling specific lots of the LogiCal Left Heart Kit (Model M205:53) for blood pressure monitoring due to potential insufficient or incomplete welds in components. This could lead to leaks or failures during use, risking inaccurate readings or device malfunction.
Insufficient or incomplete welds in specific components could cause leaks or failures during blood pressure monitoring. This might lead to inaccurate readings or device malfunction, potentially affecting patient care.
Healthcare professionals using the LogiCal Left Heart Kit for blood pressure monitoring are most at risk. Patients receiving care from these devices may also be affected if the kit fails.
Check for the model number M20553 on the LogiCal Left Heart Kit. Affected lots include 3995542, 4002489, 4016473, 4048833, and 4069387.
Look for the lot numbers 3995542, 4002489, 4016473, 4048833, or 4069387 on the LogiCal Left Heart Kit.
The model number is M20553.
Affected lots are 3995542, 4002489, 4016473, 4048833, and 4069387.
The components may have insufficient or incomplete welds, which could cause leaks or failures during blood pressure monitoring.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1473-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1473-2021 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.
