Smiths Medical recalls 250 2-gang and 3-gang manifold rotators with insufficient welds that could cause leaks in cardiac monitoring devices. Affected units include specific model numbers and lot numbers listed in the recall notice.
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 certain manifold rotators that may have insufficient or incomplete welds. This could lead to leaks in cardiac monitoring devices, potentially causing harm during medical procedures.
Insufficient welds in the manifold rotators could cause leaks in the fluid lines. This might lead to inaccurate blood pressure readings or fluid leakage during medical procedures, especially in critical care settings.
Healthcare professionals using cardiac monitoring equipment or interventional imaging devices are most at risk. Patients receiving care with these devices could be affected if the recall items are used.
Check for model numbers MX1232MR, MX1233MR, MX1322MR, or MX1333MR. Affected units have specific lot numbers listed in the recall notice: 4027757, 4076456, 3992363, 4011839, and 4016439.
Identify the model number and lot number on the device to determine if it is affected by this recall.
Reach out to Smiths Medical for further assistance if you have the affected model and lot numbers.
Insufficient or incomplete welds in the manifold rotators could cause leaks in fluid lines, potentially leading to inaccurate blood pressure readings or fluid leakage during medical procedures.
Model numbers MX1232MR (lot 4027757), MX1233MR (lot 4076456), MX1322MR (lots 3992363 and 4011839), and MX1333MR (lot 4016439) are affected.
No, but you should check if your device is affected and contact Smiths Medical if you have the specific model and lot numbers listed in the recall.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1476-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1476-2021 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.
