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Open, Classified

medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

FDA Recall Z-0195-2025 · Posted 2024-10-23

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusOpen, Classified
Product CodeDPT
Date Initiated2024-09-24
Product Quantity1110 units

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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