FDAClass IIOctober 30, 2024

Medex Transtar Monitoring KIT 1/ea recall

medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

Why was Medex Transtar Monitoring KIT 1/ea recalled?

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 50351688551694 (case), 10351688551696 (pouch), Lot Numbers: 4270117

Product
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Recalling firm
Smiths Medical ASD, Inc.
Quantity
400 units
Distribution
Worldwide distribution.
Recall date
October 30, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls