Medex recallZ-0198-2025 · Smiths Medical ASD, Inc. · initiated Sep 24, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0198-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 24, 2024
- Posted by the FDA
- Oct 23, 2024
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 900 units
- Product code
- DPT
- Distribution
- Worldwide distribution.
Product description
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Code information (models, lots, serial numbers)
UDI/DI 50351688503082 (case), 10351688503084 (pouch), Lot Numbers: 4226214, 4346067, 4350021, 4359831
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medex MX9544Icu Medical, Inc. · PROBE, BLOOD-FLOW, EXTRAVASCULAR1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95438).
- Z-0182-2025 · Open, Classifiedmedex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
- Z-0183-2025 · Open, Classifiedmedex TranStar Single ICP Set 1/EA, Product Code REF MX20897
- Z-0184-2025 · Open, Classifiedmedex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
- Z-0185-2025 · Open, Classifiedmedex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
- Z-0186-2025 · Open, Classifiedmedex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
- Z-0187-2025 · Open, Classifiedmedex Arterial Kit 1/EA, Product Code REF MX7827
- Z-0188-2025 · Open, Classifiedmedex TranStar Disposable Transducer 1/EA, Product Code REF MX950
- Z-0189-2025 · Open, Classifiedmedex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
- Z-0190-2025 · Open, Classifiedmedex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
- Z-0191-2025 · Open, Classifiedmedex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
- Z-0192-2025 · Open, Classifiedmedex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
- Z-0193-2025 · Open, Classifiedmedex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
- Z-0194-2025 · Open, Classifiedmedex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
- Z-0195-2025 · Open, Classifiedmedex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
- Z-0196-2025 · Open, Classifiedmedex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
- Z-0197-2025 · Open, Classifiedmedex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
- Z-0199-2025 · Open, Classifiedmedex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
- Z-0200-2025 · Open, Classifiedmedex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
- Z-0201-2025 · Open, Classifiedmedex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
- Z-0203-2025 · Open, Classifiedmedex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
- Z-0204-2025 · Open, Classifiedmedex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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