FDA Device recall Z-0663-2014

31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConne…

FDA Device
Class II
terminated
Published 2014-01-15

On 2014-01-15 the FDA classified a Class II recall of 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConne… 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

Agency	FDA Device
Recall number	Z-0663-2014
Classification	Class II
Status	terminated
Initiated	2013-12-24
Published	2014-01-15
Last updated	2026-09-13 11:53 UTC
Company	Icu Medical
Distribution	AL, CA, GA, HI, IL, IN, KY, NC, NH, OH, TN, TX, UT, VT, WI

Product

31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1097 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_info	Item No. 011-A1097. Lot No. 2781155, 2796667.

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-0663-2014%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.