RecallRadar

FDA Device recall Z-0676-2014

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 C…

On 2014-01-15 the FDA classified a Class II 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 C… by Icu Medical, citing ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0676-2014
ClassificationClass II
Statusterminated
Initiated2013-12-24
Published2014-01-15
Last updated2026-09-13 11:53 UTC
CompanyIcu Medical
DistributionAL, CA, GA, HI, IL, IN, KY, NC, NH, OH, TN, TX, UT, VT, WI

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.

Reason

ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

Identifiers

code_infoLot No. 2777116

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0676-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.