Smiths Medical Recalls Left Heart Kits Due to Incomplete Welds
Smiths Medical ASD Inc. is recalling specific lots of Left Heart Kits and related components 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 involves a medical device with a structural defect (incomplete welds) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, Tubing, and Medex LogiCal Kits. These components are used in various cardiac kits, including pressure monitoring devices and interventional imaging devices.
The recall was initiated because the affected components may have been manufactured with insufficient or incomplete welds. The specific lots involved are 4002486, 4019146, and 4036647. The recall covers 600 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. Users should contact Smiths Medical ASD Inc. for further instructions regarding the recall.
The recalled product
- Product
- Left Heart Kit, Model Number M20268. for blood pressure monitoring.
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 600
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 (3)
- Lot Numbers: 4002486
- 4019146
- 4036647
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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