Recalls / —
—#210276
Product
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
- FDA product code
- DPT — Probe, Blood-Flow, Extravascular
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- UDI/DI 50351688504041 (case), 10351688504043 (pouch), Lot Numbers: 4270150, 4277661, 4277716, 4287633
Why it was 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.
Root cause (FDA determination)
Process control
Action the firm took
Smiths 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.
Recalling firm
- Firm
- Smiths Medical ASD, Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Worldwide distribution.
Timeline
- Recall initiated
- 2024-09-24
- Posted by FDA
- 2024-10-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #210276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.