RecallRadar

FDA Device recall Z-0705-2014

6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp,…

On 2014-01-15 the FDA classified a Class II recall of 6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp,… 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-0705-2014
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

6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. 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_infoItem # A1099, Lot # 2791393.

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-0705-2014%22

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