Smiths Medical recalls Medex High Pressure Stopcocks with potential leaks. These single-use IV devices may leak if defective. Check model numbers and lot numbers listed to see if your item is affected.
Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924
Smiths Medical is recalling Medex High Pressure Stopcocks that may leak due to a manufacturing defect. This could cause IV fluid to leak, potentially leading to infection or other complications if the device is used.
The stopcocks have a defect in the inner body that can cause leaks. Leaks may lead to IV fluid escaping from the tubing, which could increase the risk of infection or other complications if the device is used.
Healthcare professionals who use IV devices or patients receiving IV treatments with these stopcocks. Those with the specific model numbers and lot numbers listed are most at risk.
Check the model number and lot number on the stopcock. Affected items have model numbers MX4301L (lot 3538569), MX4331L (lots 3562377 and 3546826), or MX4331R (lot 3546924).
Look for the model number and lot number on the stopcock to see if it matches the affected items listed.
Certain lots of Medex High Pressure Stopcocks were manufactured with an inner body defect that may result in leaks.
Model numbers MX4301L (lot 3538569), MX4331L (lots 3562377 and 3546826), and MX4331R (lot 3546924).
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0512-2019 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0512-2019 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.
