Reported Oct 29, 2025 · Ongoing

IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm)…

ICU Medical, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212

Is this the product you have?

5 products · 10 lot codes

  1. B3335923" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp

    UDI-DI
    10887709007823

    2 recalled lot codes

    • 14070544
    • 14126963
  2. B921370" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext

    UDI-DI
    10840619045859

    1 recalled lot code

    • 14130197
  3. B973280" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext

    UDI-DI
    10887709015033

    1 recalled lot code

    • 14149636
  4. B973353 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap

    UDI-DI
    10887709015040

    1 recalled lot code

    • 14176779

Page 1 of 2

Amount recalled
23203

Where it was sold

Why it was recalled

Stop using this product now

IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.