Z-0203-2025Class II

medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

Name: Z-0203-2025 medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Creator: Smiths Medical ASD, Inc.
Published: 2024-09-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-09-24 / Open, Classified / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1 on 2024-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0203-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-24
Posted: 2024-10-23
Recalling firm: Abbott Medical
Product: medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Product code: DPT Probe, Blood-Flow, Extravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 3080 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 50351688518123 (case), 10351688518125 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0203-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0182-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0183-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0184-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0185-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0186-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0187-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0188-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0189-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0190-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0191-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0192-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0193-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0194-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0195-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0196-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0197-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0198-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0199-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0200-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0201-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0202-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0203-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0204-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0205-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23

Product code DPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)