ICU Medical, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0980-2017)

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:

133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer.

Product Classification:

Class II

Date Initiated: November 30, 2016

Date Posted: January 18, 2017

Recall Number: Z-0980-2017

Event ID: 75895

Reason for Recall:

ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.

Status: Terminated

Product Quantity: 225 units

Code Information:

Lot No. 3323650

Distribution Pattern:

US: NC

Voluntary or Mandated:

Voluntary: Firm initiated