The Recall Desk
HighFDA (Devices)·Z-0195-2021·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.

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 compromise the sterile seal, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 109-inch NanoClave intravascular administration sets. The recall involves a total of 304,735 units distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected product is a single-use, sterile, non-pyrogenic device used for the administration of fluids from a container to a patient's vascular system.

Healthcare facilities and consumers should stop using the affected lots of NanoClave sets and contact ICU Medical for further instructions or a replacement. The specific lot number identified in the recall is 4590844.

The recalled product

Product
109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709066417(17)250101(30)50(10)45
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:4590844.

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

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Same hazard · seal defect

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