Agency classClass IIOur severity:High FDA (Devices)·Z-0212-2021·Announced 2020-10-28

ICU Medical NanoClave Stopcock Recalled for Potential Manufacturing Defect

ICU Medical is recalling NanoClave Stopcocks due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 inhibit a proper seal, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling NanoClave Stopcocks with an integral CLAVE side-port. The recall is 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 a four-way stopcock used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. The specific lot number is 4572842. The total quantity of affected products is 304,735 units.

The 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 facilities and consumers should stop using the affected devices and contact the recalling firm for further instructions.

The recalled product

Product: NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion / IV
Hazard: manufacturing-defect
seal-failure

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:4572842.

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 →

Same manufacturer · ICU Medical, Inc.

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