ICU Medical, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2720-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), 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)..

Product Classification:

Class II

Date Initiated: May 30, 2017

Date Posted: July 19, 2017

Recall Number: Z-2720-2017

Event ID: 77560

Reason for Recall:

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

Status: Terminated

Product Quantity: 70 units

Code Information:

Lot No. 3316827. Item No. 011-AM6118

Distribution Pattern:

Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.

Voluntary or Mandated:

Voluntary: Firm initiated