ICU Medical B30201Recalls & reported problems

Icu Medical, Inc. · 150" 10 Drop Primary Set w/4 Pre-Slit Ports, Remv 4-Way Stopcock (Yellow Cap), 2 Exts, 1 Pressure Infusion (400psig) Ext, Spin Luer · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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.

7 other recalls cover devices cleared under the same FDA submission (K100576); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

May 12, 2026Class IIOpen, Classified
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Z-3160-2026 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100576. One submission often covers many models, so check the product and lot details in each record.

Z-1720-2022 · Aug 1, 2022 · Open, Classified
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Z-0201-2021 · Jul 6, 2020 · Terminated
7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case.
Z-0197-2021 · Jul 6, 2020 · Terminated
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multi
Z-0193-2021 · Jul 6, 2020 · Terminated
6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouche
Z-0192-2021 · Jul 6, 2020 · Terminated
9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 mul
Z-0204-2021 · Jul 6, 2020 · Terminated
6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per
Z-1916-2020 · Oct 4, 2019 · Terminated
REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889

Device details

UDI-DI	`00887709055629`
Brand	ICU Medical
Model	B30201
Company	Icu Medical, Inc.
Product code	FPA · Set, administration, intravascular
Class	Class 2
FDA submission	K100576
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 24, 2023

Device type (GMDN): Basic intravenous administration set, noninvasive

A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Other Set, administration, intravascular devices

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1 death16,105 reports
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Minimed™ Quick-set™ MMT-399A
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9 deaths8,669 reports
Medtronic Extended MMT-431A
Unomedical A/S · Set, Administration, Intravascular
3 deaths8,574 reports
MiniMed™ Mio™ Advance MMT-242A
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CADD 21-7302-24
Icu Medical, Inc. · Set, administration, intravascular
4 recalls1 death4,657 reports
Autosoft XC 1001681
Unomedical A/S · Set, Administration, Intravascular
1 death4,216 reports
Minimed™ Quick-set™ MMT-397A
Unomedical A/S · Set, Administration, Intravascular
19 deaths4,134 reports

All Set, administration, intravascular devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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