The Recall Desk
HighFDA (Devices)·Z-0208-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

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 failure of a sterile seal in a medical device, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 12-inch smallbore extension sets equipped with NanoClave technology. The recall involves a total of 304,735 units distributed worldwide, including across the United States and in countries such as 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. This defect may inhibit a proper seal with the NanoClave spike. The affected products are sterile, single-use intravascular administration sets used to provide access for the administration of fluids from a container to a patient's vascular system.

Healthcare facilities and distributors should stop using the affected lots immediately. The specific lot numbers involved are 4572814, 4724859, and 4734417. Users should check their inventory for these lot numbers and contact ICU Medical for further instructions on the return or replacement of the devices.

The recalled product

Product
12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265; (01)10887709087526(17)250201(30)50(10)4724859; (01)10887709087526(17)250201(30)50
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:4572814
  • 4724859
  • 4734417.

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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