[pending] IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF:
Pending LLM rewrite. Source: FDA_DEVICE Z-0154-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 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,
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
Distribution
Distributed nationwide across the United States.
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