RecallRadar

FDA Device recall Z-0701-2014

5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358

On 2014-01-15 the FDA classified a Class II recall of 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358 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-0701-2014
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

5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. 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 # B33101-T, Lot # 2791358.

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-0701-2014%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.