Z-1589-2015Class II

107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item...

Name: Z-1589-2015 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item...
Creator: ICU Medical, Inc.
Published: 2015-04-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-04-20 / Terminated

FDA source

ICU Medical, Inc. began a recall of 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets... on 2015-04-20. FDA classified it as Class II and gives the reason as "ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1589-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-20
Posted: 2015-05-07
Terminated: 2015-11-24
Recalling firm: Abbott Medical
Product: 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Product code: FMG Stopcock, I.V. Set
Reason for recall: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall letter dated 4/17/15 will be sent to customers on 4/20/15 to inform them that ICU Medical Inc. has identified a potential connection separation issue in a small number of isolated Intravenous Administration Transfer Sets. While the separation may be visually detected, if used, this failure mode could lead to leakage. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return completed recall response form to ICU Medical by Fax at (801) 264-1755 or email to [email protected]. Customers with questions or require assistance relating to the recall are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected].
Quantity in commerce: 600 units
Distribution: Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
Product codes and lots: Lot No. 3002665 3004236 2995225

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1589-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1588-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-07
Z-1589-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-07
Z-1590-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-07
Z-1591-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-07
Z-1592-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-07
Z-1593-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-07
Z-1594-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-07
Z-1595-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-07

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)