The Recall Desk
HighFDA (Devices)·Z-0193-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Pressure Infusion Extension Sets

ICU Medical is recalling specific lots of smallbore pressure infusion extension 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 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 6.5-inch (17 cm) smallbore pressure infusion extension sets. 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 the identification of a potential manufacturing defect on the internal surface of the NanoClave component within the affected sets. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4558455, 4537168, and 4493389.

Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062525(17)250101(30)50(10)4558455; (01)10887709062525(17)241201(30)50(
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 (3)

  • Lot Numbers:4558455
  • 4537168
  • 4493389.

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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