Agency classClass IIOur severity:High FDA (Devices)·Z-0280-2021·Announced 2020-10-28

ICU Medical Recalls SURPLUG Nano Connectors Due to Manufacturing Defect

ICU Medical is recalling SURPLUG Nano Connectors because a manufacturing defect on the internal surface of the NanoClave may inhibit 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 inhibit a proper seal, creating a risk of harm (such as fluid leakage or infection) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

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

The affected product is the SURPLUG Nano Connector, packaged as 1 unit per pouch with 100 multivac pouches per case. The specific lot number is 4476418. The total quantity of affected products is 304,735 units.

These 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 providers and facilities should stop using the affected lots and contact ICU Medical for instructions on return or replacement.

The recalled product

Product: SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)4476418. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
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:4476418.

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