medex TranStar Single OR Set 1/EA recall
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Why was medex TranStar Single OR Set 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 50351688508780 (case), 10351688508782 (pouch) , Lot Numbers: 4282732, 4287721
- Product
- medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 260 units
- Distribution
- Worldwide distribution.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)