Agency classClass IIOur severity:High FDA (Devices)·Z-0213-2021·Announced 2020-10-28

ICU Medical NanoClave Stopcock Manifold Recalled for Manufacturing Defect

ICU Medical is recalling specific lots of NanoClave Stopcock Manifolds 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 is classified as FDA Class II, and the hazard involves a potential seal failure in a medical device used for vascular access, which poses a risk of harm even though no injuries have been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of the 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer. The recall involves a total of 304,735 units distributed worldwide, including across the United States and in Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. The affected lot numbers are 4493459 and 4536673.

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 device is 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.

Healthcare facilities and distributors should stop using the affected devices and contact ICU Medical for further instructions. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product: 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)241201(30)50(10)4536673. The ICU Medical Clave Stopcock is a device used to administer or…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion / Stopcock
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 (2)

Lot Numbers:4493459
4536673.

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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Same hazard · manufacturing defect