Z-0980-2017Class II

133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006

Name: Z-0980-2017 133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006
Creator: ICU Medical, Inc.
Published: 2016-11-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-11-30 / Terminated

FDA source

ICU Medical, Inc. began a recall of 133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is... on 2016-11-30. FDA classified it as Class II and gives the reason as "ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0980-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-30
Posted: 2017-01-10
Terminated: 2017-06-23
Recalling firm: Abbott Medical
Product: 133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer.
Product code: FMG Stopcock, I.V. Set
Reason for recall: ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
FDA root cause: Mixed-up of materials/components
Action: An Urgent Medical Device Recall Notification letter dated 11/30/16 was sent to their customers to inform them that ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber. The letter instructs the customers of the actions required and to return completed recall response form to ICU Medical via fax (801) 264-1755 or by email [email protected]. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between 8:30AM and 4PM Pacific Time, (866) 829-9025 and select option 2 or email [email protected].
Quantity in commerce: 225 units
Distribution: US: NC
Product codes and lots: Lot No. 3323650

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0980-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0980-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

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)