FDA Device recall Z-0980-2017

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…

• FDA Device
• Class II
• terminated
• Published 2017-01-18

On 2017-01-18 the FDA classified a Class II recall of 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… by Icu Medical, citing 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.

Read the official FDA Device notice

Product

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.

Reason

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.

Identifiers

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-0980-2017%22

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