Smiths Medical Recalls LogiCal Left Heart Kits Due to Weld Defects
Smiths Medical ASD Inc. is recalling specific lots of LogiCal 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for medical devices with potential for temporary or medically reversible health consequences.
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 items are components used in various cardiac kits, including pressure monitoring devices and interventional imaging devices.
The recall was initiated because the affected products may have been manufactured with insufficient or incomplete welds. This defect could potentially compromise the integrity of the medical devices used in cardiac procedures.
The recall involves 3,740 devices distributed nationwide in the United States, including Puerto Rico, as well as in Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan. The specific lot numbers affected are 3995542, 4002489, 4016473, 4048833, and 4069387. Healthcare facilities and consumers should check their inventory for these lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 3,740
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 (5)
- Lot Numbers: 3995542
- 4002489
- 4016473
- 4048833
- 4069387
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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