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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Smiths Medical ASD, Inc.: Medex TranStar Disposable Pressure Transducers Recalled for Monitoring Failure

Agency Publication Date: October 23, 2024
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Summary

Smiths Medical ASD, Inc. is recalling over 1.1 million Medex TranStar Disposable Pressure Transducers and monitoring kits because of a manufacturing defect in the device's chip or a potential internal leak. These medical devices are used to monitor blood pressure or intracranial pressure in patients. The defect can cause the device to show inaccurate pressure readings, stop monitoring entirely, or fail to reset (zero) properly, which could lead to incorrect clinical decisions.

Risk

A leak or chip defect in the transducer can lead to false high or low pressure readings; for instance, an inaccurate reading could delay necessary treatment for dangerous changes in blood pressure or brain pressure, potentially causing serious harm. While the recall is ongoing, no specific incident or injury counts were provided in the initial data.

What You Should Do

  1. Identify if you have any of the 24 affected Medex TranStar products by checking the Product Code (REF) and Lot Numbers on the packaging or device pouch.
  2. Check for specific lot numbers such as 4277670, 4287645, 4299776, or 4323148 for the widely distributed 84-inch monitoring kits (REF MX9505T).
  3. Verify other affected models including the medex TranStar Single OR Set (Lot 4282732, 4287721), Arterial Kit (Lots 4282733, 4319605, 4340472), and various KIDS KITS (Lots 4297925, 4340497, 4226214, 4323136).
  4. Contact your healthcare provider or the manufacturer, Smiths Medical ASD, Inc., immediately to determine the specific corrective actions required for your inventory and to discuss potential refunds or replacements.
  5. If you are a medical professional, monitor for signs of inaccurate pressure readings or an inability to zero the device and replace any suspected faulty units immediately.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: medex TranStar Single OR Set 1/EA
Model / REF:
MX20846R2
UPC Codes:
50351688508780
10351688508782
Lot Numbers:
4282732
4287721
Product: medex TranStar Single ICP Set 1/EA
Model / REF:
MX20897
UPC Codes:
50351688508551
10351688508553
Lot Numbers:
4323116
Product: medex NICU Monitoring Kit Set 1/EA
Model / REF:
MX20086
UPC Codes:
50351688509817
10351688509819
Lot Numbers:
4270117
Product: medex TRANSTAR MONITORING KIT 1/EA
Model / REF:
MX20103R1
UPC Codes:
50351688551694
10351688551696
Lot Numbers:
4270117
Product: medex TranStar Kit w/ Stopcock 1/EA
Model / REF:
MX20740
UPC Codes:
50351688508957
10351688508959
Lot Numbers:
4273609
Product: medex Arterial Kit 1/EA
Model / REF:
MX7827
UPC Codes:
50351688505185
10351688505187
Lot Numbers:
4282733
4319605
4340472
4355338
4390060
4411161
Product: medex TranStar Disposable Transducer 1/EA
Model / REF:
MX950
UPC Codes:
50351688504126
10351688504128
Lot Numbers:
4293125
4328466
4277644
4349995
4363255
Product: medex TranStar Patient Mount Monitoring Kit 10/EA
Model / REF:
MX9501T
UPC Codes:
50351688504072
10351688504074
Lot Numbers:
4304896
4346065
4355385
4376424
Product: medex TranStar 72in (183cm) Double Monitoring Kit 10/EA
Model / REF:
MX9502T
UPC Codes:
50351688504041
10351688504043
Lot Numbers:
4270150
4277661
4277716
4287633
Product: medex TranStar 60in (152cm) Single Monitoring Kit 10/EA
Model / REF:
MX9504T
UPC Codes:
50351688504034
10351688504036
Lot Numbers:
4277662
4287634
4289405
Product: medex TranStar 84in (213cm) Single Monitoring Kit 10/EA
Model / REF:
MX9505T
UPC Codes:
50351688503990
10351688503992
Lot Numbers:
4277670
4287645
4287649
4299776
4277696
4308930
4299811
4308934
4299812
4323148
4264943
4264939
4277694
4264950
4299779
4308962
4323175
4328515
4299788
4299789
4299790
4299801
4299802
4308954
4308959
4308963
4321917
4308947
4334499
4299786
4355732
4355735
4346115
4299780
4355730
4355727
4334501
4346096
4346097
4346124
4355733
4346109
4355728
4355740
4355750
4355749
4355746
4346120
4355757
4355753
Product: medex TranStar DPT w/Stopcock & 3cc Flush 10/EA
Model / REF:
MX950SCFT
UPC Codes:
50351688503945
10351688503947
Lot Numbers:
4277663
Product: medex TranStar DPT w/Stopcock & 30cc Flush 10/EA
Model / REF:
MX950SCNT
UPC Codes:
50351688503938
10351688503930
Lot Numbers:
4293126
4309186
4316649
4323123
4328467
4346049
Product: medex TranStar DPT w/Two Stopcocks 10/EA
Model / REF:
MX950X2SC
UPC Codes:
50351688503921
10351688503923
Lot Numbers:
4363257
4385760
Product: medex TranStar Neonatal Monitoring Kit 10/EA
Model / REF:
MX9530T
UPC Codes:
50351688503280
10351688503282
Lot Numbers:
4282765
4307302
4309198
4311461
4316668
4328487
4350011
4366881
Product: medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA
Model / REF:
MX9543
UPC Codes:
50351688503099
10351688503091
Lot Numbers:
4297925
4340497
4355387
Product: medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA
Model / REF:
MX9544
UPC Codes:
50351688503082
10351688503084
Lot Numbers:
4226214
4346067
4350021
4359831
Product: medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA
Model / REF:
MX9545
UPC Codes:
50351688503068
10351688503060
Lot Numbers:
4323136
Product: medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA
Model / REF:
MX9547
UPC Codes:
50351688503013
10351688503015
Lot Numbers:
4223699
4248326
4297927
4323137
4340498
4346068
4350022
Product: medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA
Model / REF:
MX9548
UPC Codes:
50351688503006
10351688503008
Lot Numbers:
4221225
4250996
4297929
4304897
4316671
4323138
4328494
4387189
4404713
Product: medex TranStar Stopcock w/Ext. 10/EA
Model / REF:
MXG300242
UPC Codes:
50351688517782
10351688517784
Lot Numbers:
4346040
4385749
4400278
4440647
Product: medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA
Model / REF:
MXG300243R1
UPC Codes:
50351688518123
10351688518125
Lot Numbers:
4282765
4307302
4309198
4311461
4316668
4328487
4350011
4366881
Product: medex TranStar MONITORING SET W/SAMPLING PORT 10/EA
Model / REF:
MXG300260
UPC Codes:
50351688518833
10351688518835
Lot Numbers:
4270120
4297963
4316640
4319604
4323118
4287727
4359814
4387976
4340473
Product: smiths medical SurgiVet Advisor Tech Accessories
Model / REF:
V2714
Lot Numbers:
6000465
6000466

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95438
Status: Active
Manufacturer: Smiths Medical ASD, Inc.
Sold By: authorized medical distributors; specialty healthcare suppliers
Manufactured In: United States
Units Affected: 23 products (260 units; 100 units; 50 units; 400 units; 260 units; 2232 units; 1100 units; 1740 units; 6590 units; 5880 units; 1160168 units; 10 units; 1000 units; 1110 units; 2580 units; 800 units; 900 units; 250 units; 3280 units; 3490 units; 380 units; 3080 units; 1640 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.