CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
Medex 700PSI Stopcock W/Rotator, List Number MX4331R recalled
Smiths Medical Asd is recalling Medex 700PSI Stopcock W/Rotator, List Number MX4331R, 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-0742-2024
- 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
- Packaging Defects
- 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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Questions about this recall
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: 4355397 4380735 4387234 4404740
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 93506This product is part of a recall event; the main page for the event is Inj Line Rotating Adapt (900psi), List Number MX694R recalled.
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