Smiths Medical recalls angiographic kits with model MX1030 and specific lot numbers due to potential insufficient welds in components, which could lead to leaks or failures during medical procedures.
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 angiographic kits with model number MX1030 and specific lot numbers because some components may have insufficient or incomplete welds. This could cause leaks or failures during medical procedures, potentially leading to serious complications.
Insufficient or incomplete welds in the kit's components could cause leaks or failures during medical procedures. This might lead to complications such as inaccurate pressure readings or equipment malfunction, which could affect patient safety.
Healthcare professionals using these kits during angiography or other medical procedures are most at risk. Patients undergoing these procedures may also be affected if the kit fails.
Check for the model number MX1030 on the kit and lot numbers 3979813, 3982717, 4016454, or 4024471. These kits are used during angiography and other special medical procedures.
Look for the lot numbers 3979813, 3982717, 4016454, or 4024471 on the kit packaging or label.
The recalled kit has model number MX1030.
Lot numbers 3979813, 3982717, 4016454, and 4024471 are affected.
The components may have insufficient or incomplete welds, which could cause leaks or failures during medical procedures.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1475-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1475-2021 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.
