Agency classClass IIOur severity:High FDA (Devices)·Z-1573-2021·Announced 2021-05-19

ICU Medical Recalls Oncology Kits Due to Molding Defect

ICU Medical is recalling specific lots of Oncology Kits with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.

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 could lead to fluid leakage, representing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of REF CL3946 Oncology Kits. These kits include a 5-inch (13 cm) Add-On Set with a ChemoLock Additive Port, Vented Cap, and Spinning Spiros with a Red Cap. The product is used to provide access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter.

The recall is being conducted due to a molding defect. This defect creates a potential for certain lots of spinning and non-spinning Sprios male luers to exhibit small amounts of leakage in the inactivated position.

The affected products were distributed worldwide, including nationwide distribution in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. The specific lot number identified in the recall is 5142959. Users should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product: REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Sets
Hazard: leakage
molding-defect

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 26 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 26 products in this recall →

Same manufacturer · ICU Medical, Inc.

See all →

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Same hazard · leakage