Smiths Medical Recalls 50 medex NICU Monitoring Kits Due to Defect
Smiths Medical ASD, Inc. is recalling 50 medex NICU Monitoring Kits due to a manufacturing defect that may cause inaccurate pressure monitoring.
What this means for you
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 and involves a medical device defect that could lead to inaccurate monitoring or inability to zero the device, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 50 units of the medex NICU Monitoring Kit Set 1/EA (Product Code REF MX20086). The recall is due to a manufacturing defect in the TranStar Disposable Pressure Transducer or its chip, which may result in a leak.
This defect may cause users to experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device. The affected products were distributed worldwide.
Users should stop using the affected monitoring kits and contact Smiths Medical ASD, Inc. for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 50
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)
- UDI/DI 50351688509817 (case)
- 10351688509819 (pouch)
- Lot Numbers: 4270117
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 24 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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