Agency classClass IIOur severity:High FDA (Devices)·Z-0274-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal with the 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 compromise the seal, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave administration sets. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries. The affected lot number is 4536666.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the affected sets. This defect may inhibit a proper seal with the NanoClave spike. Administration sets are single-use, pre-sterilized medical devices used to provide access for the administration of fluids from a container to a patient's vascular system.

Healthcare facilities and distributors should stop using the affected units and contact ICU Medical for further instructions. Consumers are advised to check the lot number on their devices and contact their healthcare provider if they have used the affected products.

The recalled product

Product: 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709099859(17)241201(30)50(10)4536666. Administration sets and their accessories are single use, pre-sterilized devices that…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Administration Sets
Hazard: seal-defect
fluid-leakage

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:4536666.

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 · seal defect