The Recall Desk
HighFDA (Devices)·Z-0240-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.

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 involves a medical device with a defect that may compromise the sterile seal, posing a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of NanoClave intravascular administration sets. The recall involves a total of 304,735 units of the 11-inch (28cm) small bore set with a 6-port NanoClave manifold. These devices are single-use, sterile, non-pyrogenic sets used to administer fluids from a container to a patient's vascular system.

The recall was initiated due to the identification of 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 lot number is 4557643.

The affected products were distributed worldwide, including nationwide in the United States and in countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product
11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access fo
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 (1)

  • Lot Number:4557643.

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

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Same hazard · seal defect

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