RecallRadar

FDA Device recall Z-2723-2017

10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer

On 2017-07-19 the FDA classified a Class II recall of 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer by Icu Medical, citing the connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2723-2017
ClassificationClass II
Statusterminated
Initiated2017-05-30
Published2017-07-19
Last updated2026-09-13 11:54 UTC
CompanyIcu Medical
DistributionAZ, OH, TX, WA

Product

10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

Reason

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

Identifiers

code_infoLot No. 3182596, 3204086, 3246762, 3263682, 3295482. Item No. AM6109

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2723-2017%22

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