Medex MX20846R2Recalls & reported problems

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K790314, K790455, K942377); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Sep 24, 2024Open, Classified
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.
Z-0182-2025 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K790314, K790455, K942377. One submission often covers many models, so check the product and lot details in each record.

Z-0185-2025 · Sep 24, 2024 · Open, Classified
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Z-0186-2025 · Sep 24, 2024 · Open, Classified
medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Z-0184-2025 · Sep 24, 2024 · Open, Classified
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Z-1549-2008 · Mar 24, 2008 · Terminated
Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. Used to administer fluids.

Device details

UDI-DI	`10351688508782`
Brand	Medex
Model	MX20846R2
Company	Icu Medical, Inc.
Product code	FPB · Filter, infusion line
Class	Class 2
FDA submission	K790314, K790455, K942377
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 17, 2025

Device type (GMDN): Invasive-pressure external transducer, single-use

A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

Other Filter, infusion line devices

NA 2N3350
Baxter International Inc. · Filter, infusion line
33 reports
Medex FS116
Icu Medical, Inc. · Filter, infusion line
30 reports
Medex MX448HFB
Icu Medical, Inc. · Filter, infusion line
27 reports
INTERLINK 1C8740
Baxter International Inc. · Filter, infusion line
10 reports
NA 2N3342
Baxter International Inc. · Filter, infusion line
8 reports
FLUID SYSTEMS ACCESSORIES 2N3368
Baxter Healthcare Corporation · Filter, infusion line
5 reports
Medex FS113
Icu Medical, Inc. · Filter, infusion line
3 reports
NA 2N3347
Baxter International Inc. · Filter, infusion line
2 reports

All Filter, infusion line devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.