Smiths Medical recalls Medex 700PSI Stopcocks with specific lot numbers due to potential medication underdose from leaks caused by an oversized O-ring.
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Smiths Medical is recalling certain Medex 700PSI stopcocks with specific lot numbers because a manufacturing defect may cause leaks during medication infusion, leading to underdosing. This could result in patients receiving less medication than intended.
The stopcock's O-ring may be oversized due to a manufacturing defect, causing leaks during medication infusion. This leak can lead to underdosing medication, which may not be detected until the patient experiences inadequate treatment.
Patients using these stopcocks for medical infusions are at risk of underdosing medication. Healthcare providers who use the stopcocks in clinical settings may also be affected.
Check the lot numbers: 4355397, 4380735, 4387234, or 4404740. The product is a Medex 700PSI stopcock with rotator sold by Smiths Medical.
Verify the lot number on your stopcock to see if it matches the recalled numbers: 4355397, 4380735, 4387234, or 4404740.
Smiths Medical recalls these stopcocks due to a manufacturing defect that may cause leaks during medication infusion, potentially leading to underdosing.
Check the lot number on your stopcock. If it matches the recalled numbers, contact Smiths Medical for instructions on how to proceed.
The recall states that underdosing medication could occur, but it does not specify a risk of serious injury. The hazard is described as potentially leading to underdosing.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0742-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0742-2024 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.