Z-2724-2017Class II

10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2...

Name: Z-2724-2017 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2...
Creator: ICU Medical, Inc.
Published: 2017-05-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-05-30 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product... on 2017-05-30. FDA classified it as Class II and gives the reason as "The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2724-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-30
Posted: 2017-06-26
Terminated: 2024-09-20
Recalling firm: Abbott Medical
Product: 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Product code: FMG Stopcock, I.V. Set
Reason for recall: The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were notified via letter on approximately 05/30/2017 and were instructed to examine their inventory, quarantine affected products, complete and return the response form, and return to ICU Medical. If there are any questions or assistance needed, customers can call ICU Customer Service Monday through Friday between 8:30 AM and 4:00 PM Pacific time: 866-829-9025. Or they can email: [email protected].
Quantity in commerce: 100 units
Distribution: Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Product codes and lots: Lot No. 3321776. Item No. AM6122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2724-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2716-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11
Z-2717-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11
Z-2718-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11
Z-2719-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11
Z-2720-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11
Z-2721-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11
Z-2722-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11
Z-2723-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11
Z-2724-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)