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U.S. Department of Health and Human Services

Class 2 Device Recall medex TranStar

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 Class 2 Device Recall medex TranStarsee related information
Date Initiated by FirmSeptember 24, 2024
Date PostedOctober 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0185-2025
Recall Event ID 95438
510(K)NumberK942377 
Product Classification Probe, blood-flow, extravascular - Product Code DPT
Productmedex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Code Information UDI/DI 50351688551694 (case), 10351688551696 (pouch), Lot Numbers: 4270117
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactMrs. Mary J. Ferreira
845-907-1429
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionSmiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing. The notice explained the issue, potential risk, and requested the destruction of all affected product. Distributors were directed to forward the notice to their customers.
Quantity in Commerce400 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DPT
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