The Recall Desk
HighFDA (Devices)·Z-0190-2021·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 potential manufacturing defect that may inhibit 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 poses a risk of harm (improper seal) to patients, although no injuries or illnesses have been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 9-inch Smallbore Quadfuse intravascular administration 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 the identification of a potential manufacturing defect on the internal surface of the NanoClave component within the affected lots. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4568886, 4605109, 4630689, and 4733556.

Healthcare facilities and distributors should stop using the affected products and contact ICU Medical for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50(10)4568886;(01)10887709053004(17)250101(30)50(10)4605109;(01)10887709053004(17)250201(30)50(10)4630
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 (4)

  • Lot Numbers:4568886
  • 4605109
  • 4630689
  • 4733556. .

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 →

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