The Recall Desk
HighFDA (Devices)·Z-0186-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

ICU Medical is recalling specific lots of 7-inch smallbore extension sets because a manufacturing defect may prevent the NanoClave 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 7-inch (18 cm) smallbore extension sets with MicroClave, NanoClave, clamp, and rotating luer. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries.

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 lots are 4572718, 4603246, 4718507, 4537122, 4549054, and 4734370.

Healthcare facilities and distributors should stop using the affected products and contact ICU Medical for instructions on return or replacement. The FDA classifies this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)50(10)4572718; (01)10887709051048(17)250101(30)50(10)4603246; (01)10887709051048(17)250201(30)50(1
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Sets
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 (5)

  • Lot Numbers: 4572718
  • 4603246
  • 4718507
  • 4537122
  • 4549054 4734370.

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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