Official recall record
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
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-10-02
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10887709007823
- Brand on record
- ICU Medical, Inc.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-05-12 · US FDA — Medical Devices
IV Sets with drip chambers - 2026-05-12 · US FDA — Medical Devices
Plum administration sets - 2026-05-12 · US FDA — Medical Devices
Oncology sets with drip chambers
All 16 official recall notices naming ICU Medical, Inc. on this site →
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.