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
B3335923" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp
- UDI-DI
10887709007823
2 recalled lot codes
1407054414126963
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
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
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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