Smiths Medical recalls specific stopcock rotators with insufficient welds that could cause leaks in cardiac monitoring devices. Affected models include MX1431MR (lot 3995544) and others. Contact for replacement.
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 stopcock rotators that may have insufficient or incomplete welds. This could lead to leaks in critical cardiac monitoring equipment, potentially causing serious complications during medical procedures.
The stopcock rotators may have insufficient or incomplete welds, which could cause leaks in the fluid pathways. This might lead to improper fluid flow during medical procedures, potentially causing complications for patients using cardiac monitoring or interventional imaging devices.
Healthcare professionals using cardiac monitoring or interventional imaging devices with the recalled stopcock rotators are most at risk. Patients receiving care through these devices could be affected if the rotators fail.
Check for model numbers MX1431MR (lot 3995544), MX1431MRL (lots 3995545, 4011838, 4027758, 4033501, 4044959), or MX4331R (lots 3971467, 3987918) on the device.
Identify the model number and lot number on the stopcock rotator to determine if it is affected.
Reach out to Smiths Medical for replacement or further instructions if the device is affected.
The recalled models are MX1431MR (lot 3995544), MX1431MRL (lots 3995545, 4011838, 4027758, 4033501, 4044959), and MX4331R (lots 3971467, 3987918).
The stopcock rotators may have insufficient or incomplete welds, which could cause leaks in critical medical devices.
No, but you should check the model and lot number to see if it is affected. Contact Smiths Medical for replacement if needed.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1477-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1477-2021 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.
