IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 15
FDA device recall Z-0154-2026 · posted 2025-10-23 · Open, Classified
Recall details
- Recalling firm
- ICU Medical, Inc.
- 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.
- Action taken
- ICU notified consignees via email with an "URGENT MEDICAL DEVICE CORRECTION" on about 10/02/2025. Consignees were instructed to: 1) Check all inventory locations within your institution for the affected products and discontinue use. Destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3) Complete and return the attached Customer Response Form to marketaction@mailac.custhelp.com within 10 days of receipt to acknowledge your understanding of this notification. 4) If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to marketaction@mailac.custhelp.com. ICU Medical will provide replacement products to affected customers upon receipt of a complete Customer Response Form to certify product destruction. If you have any questions, contact Customer Service via email: customerservice@icumed.com or call 1-(800)-258-5361 Additional information or technical assistance.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FMG
- Quantity affected
- 23203
- Distribution
- Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.
- Date initiated
- 2025-10-02
- Date posted
- 2025-10-23
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMARY IV SET (K964435) | Icu Medical, Inc. | 1997-04-02 |