The Recall Desk
HighFDA (Devices)·Z-0232-2021·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 risk-of-harm product (intravascular device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 58-inch NanoClave intravascular administration sets. The recall involves a potential manufacturing defect on the internal surface of the NanoClave component within the affected units.

The defect may inhibit a proper seal with the NanoClave spike. The affected products are single-use, sterile, non-pyrogenic devices 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 facilities and distributors should stop using the affected lots immediately. The specific lot numbers involved are 4573460, 4589956, and 4711185. Users should check their inventory against these lot numbers and contact ICU Medical for instructions on returning the product.

The recalled product

Product
58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460; (01)10887709095298(17)250101(30)25(10)4589956; (01)10887709095298(17)250201(30)25(10)4711185.
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 (3)

  • Lot Numbers:4573460
  • 4589956
  • 4711185.

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 · manufacturing defect

See all →