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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 7,500
Distribution
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
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