—#210270

Product

medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

FDA product code: DPT — Probe, Blood-Flow, Extravascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K942377
Affected lot / code info: UDI/DI 50351688509817 (case), 10351688509819 (pouch), Lot Numbers: 4270117

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 #210270. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.