The Recall Desk
HighFDA (Devices)·Z-0199-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a manufacturing defect that may prevent a proper seal.

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, and the defect in a sterile medical device poses a risk of harm (infection or improper fluid administration) even though no specific injuries are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 9.5-inch smallbore trifuse sets equipped with NanoClave technology. The recall involves a total of 304,735 units distributed nationwide in the United States and in several international countries, including Canada, Mexico, and various nations in Europe and Asia.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike. The affected product is identified by Lot Number 4558471.

Healthcare facilities and consumers should stop using the affected lots immediately. The intravascular administration sets are single-use, sterile devices used to administer fluids to a patient's vascular system. Users should verify the lot number on their inventory against the recall notice and contact the manufacturer or their supplier for instructions on returning the product.

The recalled product

Product
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)4558471. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which pr
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number:4558471.

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 99 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 99 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

See all →

Same hazard · seal defect

See all →