Smiths Medical recalls specific lots of High Pressure Rotators with insufficient welds that could cause leaks in cardiac monitoring devices. Affected models include MX496HP and MX497HP with listed lot numbers.
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 High Pressure Rotators that may have insufficient or incomplete welds. This could lead to leaks in critical cardiac monitoring equipment, potentially causing harm during medical procedures.
Insufficient or incomplete welds in the rotators could cause leaks in the high-pressure blood monitoring systems. This might lead to inaccurate readings or equipment failure during critical medical procedures.
Healthcare professionals using cardiac monitoring devices or interventional imaging equipment are most at risk. Patients receiving care with these devices may also be affected if the equipment fails.
Check for model numbers MX496HP (lot numbers 3952480, 3974771) or MX497HP (lot numbers 3949391, 3971003) on the device. These are components used in cardiac monitoring and imaging equipment.
Identify the model number on the device to see if it matches MX496HP or MX497HP with the listed lot numbers.
Reach out to Smiths Medical for further assistance if you have the affected model numbers.
Insufficient or incomplete welds could cause leaks in high-pressure blood monitoring systems, potentially leading to inaccurate readings or equipment failure during medical procedures.
Model MX496HP with lot numbers 3952480 and 3974771, and model MX497HP with lot numbers 3949391 and 3971003.
The recall does not require immediate stop use; however, affected devices should be checked and contacted with Smiths Medical if they match the listed models and lots.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1479-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1479-2021 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.
