RecallRadar

FDA Device recall Z-2724-2017

10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotati…

On 2017-07-19 the FDA classified a Class II recall of 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotati… 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-2724-2017
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 (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, 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. 3321776. Item No. AM6122

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-2724-2017%22

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