The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0957-2021·Announced 2021-02-17

ICU Medical Recalls MicroCLAVE Intravascular Administration Sets Due to Filter Assembly Error

ICU Medical is recalling 7,500 MicroCLAVE intravascular administration sets due to incorrect filter assembly. The affected lots were distributed nationwide in the U.S. and in Belgium.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses. The defect is a manufacturing assembly error without reported adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

ICU Medical, Inc. is recalling 7,500 units of the 7 IN (18cm) APPX 0.43ml, Smallbore Set, MicroCLAVE, Filter SetSource. The recall is due to an incorrect filter assembly in the device. The product is a single-use, sterile, non-pyrogenic intravascular administration set used to provide access for the administration of fluids from a container to a patient's vascular system.

The affected product is identified by Model List Number Z3532 and UDI (01)10887709033174(17)250401(30)50(10)4795091. The specific lot number is 4795091. The total quantity of 7,500 kits covers all four lots involved in this recall.

Distribution was worldwide, including nationwide distribution in the United States across the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA, and WV, as well as in the country of Belgium. The source text does not specify the actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - 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…
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 →

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