The Recall Desk
HighFDA (Devices)·Z-0223-2021·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 because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.

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 involves a medical device with a defect that may inhibit a proper seal, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 26-inch NanoClave intravascular administration sets. The recall is due to a potential manufacturing defect on the internal surface of the NanoClave component, which may inhibit a proper seal with the NanoClave spike.

The affected product is a single-use, sterile, non-pyrogenic device used to provide access for the administration of fluids from a container to a patient's vascular system. The recall covers a total of 304,735 units distributed nationwide in the United States and in several international countries, including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

Healthcare providers and facilities should stop using the affected lots immediately and contact ICU Medical for instructions on how to return the product. Patients who have received fluids using these specific sets should consult their healthcare provider if they have concerns about the administration of their treatment.

The recalled product

Product
26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides acce
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:4718658.

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.

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Same hazard · seal defect

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