The Recall Desk
HighFDA (Devices)·Z-0264-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of NanoClave administration sets due to a manufacturing defect that may prevent 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 hazard involves a risk-of-harm product (improper seal) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 11-inch NanoClave administration sets. The recall is due to a potential manufacturing defect on the internal surface of the NanoClave component, which may inhibit a proper seal with the NanoClave spike.

The affected products are single-use, pre-sterilized devices used to administer fluids to patients. The recall covers a total of 304,735 units distributed worldwide, including in the United States and several international countries. The specific lot numbers involved are 4718517, 4514500, and 4727354.

Healthcare providers and facilities should stop using the affected lots and contact ICU Medical for further instructions. Consumers are advised to check their medical records or consult their healthcare provider if they have received these specific products.

The recalled product

Product
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; (01)10840619059801(17)241201(30)50(10)4514500; (01)10840619059801(17)250201(30)50(10)4727354. Administration sets and their acc
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:4718517
  • 4514500
  • 4727354.

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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