Agency classClass IIOur severity:High FDA (Devices)·Z-0191-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect

ICU Medical is recalling specific lots of smallbore bifuse extension sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.

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 defect poses a risk of harm to patients by potentially compromising the sterile seal of an intravascular device, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 304,735 units of 5-inch smallbore bifuse extension sets with NanoClave T-connectors. The recall involves Lot Number 4603262, which was distributed nationwide in the United States and in several international countries including Canada, Mexico, and various nations in Europe and Asia.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike, which could affect the device's ability to safely administer fluids to a patient's vascular system. The device is a single-use, sterile, non-pyrogenic intravascular administration set.

Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or disposal. Patients who have received fluids from these specific sets should consult their healthcare provider if they have concerns about their treatment.

The recalled product

Product: 5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101(30)50(10)4603262. The Intravascular Administration Set is a single use, sterile, non-pyrogenic…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: seal-defect
contamination-risk

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:4603262. .

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