Z-0154-2026Class I

IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23"...

Name: Z-0154-2026 IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23"...
Creator: ICU Medical, Inc.
Published: 2025-10-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-10-02 / Open, Classified / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of 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)... on 2025-10-02. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0154-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-10-02
Posted: 2025-10-23
Recalling firm: Abbott Medical
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, 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
Product code: FMG Stopcock, I.V. Set
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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 [email protected]. 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: [email protected] or call 1-(800)-258-5361 Additional information or technical assistance.
Quantity in commerce: 23203
Distribution: Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0154-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0154-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23

Product code FMG

K964435Class IIPrimary IV SetIcu Medical, Inc. / cleared 1997-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)