Smiths Medical recalls Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R due to potential insufficient welds in specific lots, 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 specific lots of Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R because some units may have insufficient or incomplete welds. This could cause the device to fail during use, potentially leading to serious injury if the device is used improperly.
Insufficient or incomplete welds in specific lots could cause the device to fail during use. This might lead to improper blood pressure monitoring or device malfunction, potentially causing serious injury if the device is used without proper safety checks.
Healthcare professionals using the Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R for blood pressure monitoring or interventional imaging procedures are most at risk. Patients receiving care with this specific model may also be affected.
Check for the lot number 3946994 on the Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R. This product is a component of extravascular blood-pressure transducers used in cardiac kits and interventional imaging devices.
Look for the lot number 3946994 on the Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R.
The specific lot number for this recall is 3946994.
The product being recalled is the Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, a component of extravascular blood-pressure transducers.
This product is being recalled because specific lots may have been manufactured with insufficient or incomplete welds, which could cause device 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-1481-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1481-2021 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.
