The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0255-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect on the NanoClave 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving medical devices where the defect could impact the integrity of the device's seal.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 148-inch intravascular administration sets. The recall involves a total of 304,735 units distributed worldwide, including the United States and various international countries.

The recall was initiated 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 identified by Lot Number 4603841.

These devices are single-use, sterile, non-pyrogenic sets used to provide access for the administration of fluids from a container to a patient's vascular system. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or replacement. Consumers should not use these products if they have them in their possession.

The recalled product

Product
148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access…
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard

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:4603841.

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 →

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