The Recall Desk
HighFDA (Devices)·Z-0270-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Administration Sets Due to Manufacturing Defect

ICU Medical is recalling specific lots of NanoClave administration sets due to a potential manufacturing defect on the internal surface 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 the hazard 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 165cm (65 IN) APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave administration sets. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

The recall was initiated due to the identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected product is identified by Lot Number 4553703.

These administration sets are single-use, pre-sterilized devices used to provide access for the administration of fluids from a container to a patient's vascular system. Healthcare providers and facilities should check their inventory for the specific lot number and stop using the affected units.

The recalled product

Product
165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)241201(30)50(10)4553703. Administration sets and their accessories are single use, pre-sterilized devices that provide access for
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Administration 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 (1)

  • Lot Number:4553703.

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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