Agency classClass IIOur severity:High FDA (Devices)·Z-0271-2021·Announced 2020-10-28

ICU Medical Recalls DISTALE Bifuse Extension Sets Due to Seal Defect

ICU Medical is recalling specific lots of DISTALE Bifuse Extension Sets 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 is classified as FDA Class II, and the hazard involves a risk of harm (improper seal) 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 DISTALE 203 cm (80") Bifuse Extension Sets. The recall involves 304,735 units distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. The affected lot numbers are 4537216 and 4726595.

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

Healthcare facilities and distributors should check their inventory for the affected lot numbers and stop using these specific sets. Consumers are not typically the end-users of these professional medical devices, but patients should consult their healthcare providers if they have recently received care using these specific products.

The recalled product

Product: DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap. 1 unit per pouch, 20 pouches per case. UDI:(01)10840619093201(17)241201(30)20(10)4537216…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
Hazard: manufacturing-defect
improper-seal

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:4537216
4726595.

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