Smiths Medical recalls specific lots of tubing with male luer lock adapters due to potential insufficient welds in high-pressure adaptors, which could lead to device failure during use.
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 two specific lengths of tubing with male luer lock adapters used in blood pressure monitoring systems. The recall is because some units may have been made with weak welds that could cause the tubing to fail during use, potentially leading to inaccurate readings or device malfunction.
The tubing components may have insufficient or incomplete welds, which could cause the tubing to fail under pressure. This might lead to inaccurate blood pressure readings or device malfunction during critical medical procedures.
Healthcare professionals using blood pressure monitoring systems or interventional imaging devices that include these specific tubing components are most at risk. Patients using these devices may also be affected if the tubing fails.
Check for tubing with male luer lock adapters labeled as 76 cm (REF 601280) or 122 cm (REF 607281). Look for lot numbers 3872300, 3946984 for the 76 cm tubing or 3872301, 4024481 for the 122 cm tubing.
Identify the tubing length and lot numbers to confirm if it is part of the recall.
Reach out to Smiths Medical for further assistance if you have the recalled tubing.
Smiths Medical is recalling tubing with male luer lock adapters that are 76 cm (REF 601280) or 122 cm (REF 607281).
The 76 cm tubing (REF 601280) has lot numbers 3872300 and 3946984, and the 122 cm tubing (REF 607281) has lot numbers 3872301 and 4024481.
The recall is due to potential insufficient or incomplete welds in the tubing components, which could cause failure during use.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1480-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1480-2021 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.