Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.
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: The recall is classified as FDA Class II. The hazard involves insufficient welds in medical devices used for pressure monitoring, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, and Tubing, as well as Medex LogiCal Kits. The recall involves 10 devices, specifically the Mark 910 LogiCal, Model Number DPS567201, used for blood pressure monitoring and blood sampling.
The recall was initiated because these components may have been manufactured with insufficient or incomplete welds. These parts are used in various cardiac kits, including pressure monitoring devices and interventional imaging devices.
The affected products were distributed in the United States (including Puerto Rico), Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan. The specific lot number affected is 4031331. Users should stop using these devices and contact Smiths Medical ASD Inc. for further instructions.
The recalled product
- Product
- Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 10
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 (1)
- Lot Numbers: 4031331
Distribution
Part of a larger recall action
This product is one of 12 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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