The Recall Desk
HighFDA (Devices)·Z-0218-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike 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 involves a medical device with a defect that may compromise sterility or function, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 126-inch (320 cm) 16.4 ml, 15 Drop Primary Sets equipped with NanoClave stopcocks. The recall affects a total of 304,735 units distributed worldwide, including in 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 product is a single-use, sterile, non-pyrogenic device used to administer fluids from a container to a patient's vascular system.

Healthcare facilities and distributors should identify and quarantine the affected lots. The specific lot number is 4724881. Users should stop using the affected devices and contact the manufacturer for further instructions or replacement.

The recalled product

Product
126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709070902(17)250201(30)50(10)4724881. The Intravascular Administration Set is a single use
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:4724881.

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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