ICU Medical IV Burette Administration Sets Recalled for Missing Shutoff Valve

Agency Publication Date: October 23, 2025

Summary

ICU Medical, Inc. has recalled 23,203 units of various IV Gravity burette administration sets because the burette component may be missing an internal shutoff valve. This valve is a safety feature designed to stop fluid flow automatically; its absence can lead to therapy delays, uncontrolled fluid delivery, or the dangerous infusion of air into a patient's body. The recall affects several models including 23-inch, 70-inch, 80-inch, and 21-inch add-on burette sets sold under reference numbers B33359, B9213, B9732, B9733, and 011-C7014.

Risk

The missing internal shutoff valve can result in unrestricted fluid flow (over-delivery) or allow air to enter the IV line and be infused into the patient's body. These conditions pose a risk of serious injury or death from air embolism or incorrect medication dosage.

What You Should Do

This recall involves ICU Medical IV Gravity burette administration sets (150 mL) with the following reference numbers: B33359, B9213, B9732, B9733, and 011-C7014.
Identify affected products by checking the REF number and lot number on the device packaging. The affected lot numbers are: 14070544, 14126963 (for B33359); 14130197 (for B9213); 14149636 (for B9732); 14176779 (for B9733); and 14029638, 14065820, 14110075, 14211300, 14129823 (for 011-C7014).
Stop using the recalled IV administration sets immediately and quarantine any remaining inventory to prevent clinical use.
Contact ICU Medical, Inc. or your clinical distributor to arrange for the return, replacement, or correction of the affected devices.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock

Variants: 150 mL

Model / REF:

B33359

Lot Numbers:

14070544

14126963

UDI:

10887709007823

Missing internal shutoff valve.

Product: 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp

Variants: 150 mL

Model / REF:

B9213

Lot Numbers:

14130197

UDI:

10840619045859

Missing internal shutoff valve.

Product: 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext

Variants: 150 mL

Model / REF:

B9732

Lot Numbers:

14149636

UDI:

10887709015033

Missing internal shutoff valve.

Product: 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext

Variants: 150 mL

Model / REF:

B9733

Lot Numbers:

14176779

UDI:

10887709015040

Missing internal shutoff valve.

Product: 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap

Variants: 150 mL

Model / REF:

011-C7014

Lot Numbers:

14029638

14065820

14110075

14211300

14129823

UDI:

10840619005068

Missing internal shutoff valve.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97698

Status: Active

Manufacturer: ICU Medical, Inc.

Sold By: Clinical distributors; Direct to hospitals and healthcare facilities

Manufactured In: United States

Units Affected: 23203

Distributed To: Texas, South Carolina

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 · 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.

Summary

What You Should Do

This recall involves ICU Medical IV Gravity burette administration sets (150 mL) with the following reference numbers: B33359, B9213, B9732, B9733, and 011-C7014.

Identify affected products by checking the REF number and lot number on the device packaging. The affected lot numbers are: 14070544, 14126963 (for B33359); 14130197 (for B9213); 14149636 (for B9732); 14176779 (for B9733); and 14029638, 14065820, 14110075, 14211300, 14129823 (for 011-C7014).

Stop using the recalled IV administration sets immediately and quarantine any remaining inventory to prevent clinical use.

Contact ICU Medical, Inc. or your clinical distributor to arrange for the return, replacement, or correction of the affected devices.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Affected Products

Product: 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock

Variants: 150 mL

Model / REF:

B33359

Lot Numbers:

14070544

14126963

UDI:

10887709007823

Missing internal shutoff valve.

Product: 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp

Variants: 150 mL

Model / REF:

B9213

Lot Numbers:

14130197

UDI:

10840619045859

Missing internal shutoff valve.

Product: 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext

Variants: 150 mL

Model / REF:

B9732

Lot Numbers:

14149636

UDI:

10887709015033

Missing internal shutoff valve.

Product: 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext

Variants: 150 mL

Model / REF:

B9733

Lot Numbers:

14176779

UDI:

10887709015040

Missing internal shutoff valve.

Product: 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap

Variants: 150 mL

Model / REF:

011-C7014

Lot Numbers:

14029638

14065820

14110075

14211300

14129823

UDI:

10840619005068

Missing internal shutoff valve.