Agency classClass IIOur severity:High FDA (Devices)·Z-0250-2021·Announced 2020-10-28

ICU Medical Recalls Clave Stopcock Due to Potential Manufacturing Defect

ICU Medical is recalling specific lots of Clave Stopcocks because a manufacturing defect may prevent 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 risk-of-harm product (medical device) where a defect may inhibit a proper seal, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of Clave Stopcocks. The recall is due to a potential manufacturing defect on the internal surface of the NanoClave component within the device. This defect may inhibit a proper seal with the NanoClave spike.

The Clave Stopcock is a medical device used to administer or withdraw fluids that flow from a container to a patient's vascular system. It features a four-way stopcock with an integral CLAVE side-port for closed, needleless access to patient tubing or other fluid containers.

The affected product is identified by Lot Number 4727496. The total quantity of affected units is 304,735. The product was 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 distributors should stop using the affected lots and contact ICU Medical for further instructions.

The recalled product

Product: Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. 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 through a needle or…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion / IV Components
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:4727496.

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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