CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
1050 Stopcock Left Rotator Off Handle, List Number MX1431MRL recalled
Smiths Medical Asd is recalling 1050 Stopcock Left Rotator Off Handle, List Number MX1431MRL, distributed nationwide in the US. The recall was initiated on 10 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0740-2024
- FDA event ID
- 93506
- Recalling firm
- Smiths Medical Asd, Dublin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Nov 2023
- FDA classified
- 17 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 10 Nov 2023 | Recall initiated by company | |
| 17 Jan 2024 | Classified by FDA | +68 days |
| 24 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Stores named: Walmart
Questions about this recall
Is 1050 Stopcock Left Rotator Off Handle, List Number MX1431MRL recalled?
Yes. Smiths Medical Asd recalled 1050 Stopcock Left Rotator Off Handle, List Number MX1431MRL on 10 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0740-2024.
Why was it recalled?
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.
Which lots are affected?
Lot Number: 4387166
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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