The Recall Desk
HighFDA (Devices)·Z-0235-2021·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 with the spike.

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 hazard involves a potential seal defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 10-inch NanoClave intravascular administration sets. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries. The affected product is a single-use, sterile device used to administer fluids to a patient's vascular system.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave manifold within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The source text does not report any illnesses or injuries associated with this defect.

Healthcare providers and consumers should check their inventory for the specific lot numbers listed in the recall notice: 4565730, 4713953, 4730099, 4599979, 4589962, 4711191, and 4733727. Affected units should be removed from use and returned to the manufacturer or a designated distributor for credit or replacement.

The recalled product

Product
10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(17)250201(30)50(10)4713953; (01)10887709067322(17)250201(30)50(10)4730099; (01)10887709067322(17
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 (7)

  • Lot Numbers:4565730
  • 4713953
  • 4730099
  • 4599979
  • 4589962
  • 4711191
  • 4733727.

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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