The Recall Desk
HighFDA (Devices)·Z-0958-2021·Announced 2021-02-17

ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error

ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices are distributed worldwide and across multiple U.S. states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II for a medical device with a structural defect (incorrect filter assembly). Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).

Plain-English summary

ICU Medical, Inc. is recalling 7,500 intravascular administration sets due to an incorrect filter assembly. The affected product is a single-use, sterile, non-pyrogenic device used to administer fluids from a container to a patient's vascular system. The specific product description is "154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER."

The recall covers four lots, with a total of 7,500 kits affected. Distribution was worldwide, including nationwide distribution in the United States across states such as Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Tennessee, Texas, Virginia, Washington, and West Virginia. The country of Belgium is also listed as a distribution location.

The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected devices and contact ICU Medical for further instructions or a replacement.

The recalled product

Product
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - 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 ad
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
Affected units
7,500

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 4 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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