Medex LOGICAL CATH LAB KIT Recalled for Oversized O-Ring Defect
Smiths Medical is recalling the Medex LOGICAL CATH LAB KIT due to a manufacturing defect where the O-ring inner diameter may be oversized, affecting seal integrity and potentially leading to medication under-infusion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall meets the High criteria as a risk-of-harm medical device where potential medication under-infusion could impact patient treatment, but no illnesses or injuries have been reported. The FDA Class II classification without reported hospitalizations indicates a defect requiring correction.
Plain-English summary
Smiths Medical Asd Inc is recalling the Medex LOGICAL CATH LAB KIT (List Number M20754, UDI-DI: 10351688510686) due to a manufacturing defect affecting specific rotator lots.
The issue involves an oversized inner diameter of the device's O-ring, which may compromise seal integrity. An inadequate seal could allow leakage during medication infusion, potentially resulting in under-infusion of the prescribed medication.
This recall affects 31,685 units that have been distributed nationwide in the United States as well as in Canada and the United Arab Emirates. The affected lot number is 4371054.
Healthcare facilities and providers who have received this product should immediately stop using affected units and contact Smiths Medical for instructions on return or replacement. Consult the FDA website for further details and updates regarding this recall.
The recalled product
- Product
- Medex LOGICAL CATH LAB KIT, List Number M20754
- Manufacturer
- Smiths Medical Asd Inc
- Category
- Medical Device — Infusion System
- Affected units
- 31,685
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 10351688510686
- Lot Number: 4371054
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Smiths Medical Asd Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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