Z-0676-2014Class II

13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item...

Name: Z-0676-2014 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item...
Creator: ICU Medical, Inc.
Published: 2013-12-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-12-24 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single... on 2013-12-24. FDA classified it as Class II and gives the reason as "ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may 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-0676-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-24
Posted: 2014-01-09
Terminated: 2014-04-01
Recalling firm: Abbott Medical
Product: 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
Product code: FPA Set, Administration, Intravascular
Reason for recall: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: icumedical sent an Urgent Medical Device Recall letter dated December 24, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to return completed verification forms. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30AM and 4:00PM Pacific Time: (866) 829-9025 and select option 8, or email: [email protected]. ICU Medical reported an update on January 6, 2014, an expansion of the recall to additional lots. Updated recall letter was sent out to all customers on additional lots on January 6, 2014 via UPS with tracking. For questions regarding this recall call 949-366-2183.
Quantity in commerce: 25 units
Distribution: Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
Product codes and lots: Lot No. 2777116

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0676-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0658-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0659-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0660-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0661-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0662-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0663-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0664-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0665-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0666-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0667-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0668-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0669-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0670-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0671-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0672-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0673-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0674-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0675-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0676-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0677-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0678-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0679-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0680-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0681-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0682-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0683-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0684-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0685-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0686-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0687-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0688-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0689-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0690-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0691-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0692-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0693-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0694-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0695-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0696-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0697-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0698-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0699-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0700-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0701-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0702-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0703-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0704-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0705-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0706-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0707-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09

Product code FPA

K970855Class IIClave ConnectorIcu Medical, Inc. / cleared 1997-06-24

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)