IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, R...
FDA Recall #Z-0154-2026 — Class I — October 2, 2025
Product Description
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
Reason for Recall
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.
Recalling Firm
ICU Medical, Inc. — San Clemente, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
23203
Distribution
Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.
Code Information
REF/UDI-DI/Lot: B33359/10887709007823/14070544, 14126963; B9213/10840619045859/14130197; B9732/10887709015033/14149636; B9733/10887709015040/14176779; 011-C7014/10840619005068/14029638, 14065820, 14110075, 14211300, 14129823
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated