The Recall Desk
HighFDA (Devices)·Z-0260-2021·Announced 2020-10-28

ICU Medical Recalls 124 Inch Burette Sets Due to Manufacturing Defect

ICU Medical is recalling specific lots of 124-inch burette sets because a manufacturing defect may prevent the NanoClave from sealing properly.

What this means for you

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 potential failure of a medical device seal which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 124-inch (315 cm) 60 Drop 150 mL Burette Sets. The recall involves a total of 304,735 units distributed worldwide, including in the United States and several international countries.

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. The affected product is a single-use, sterile, non-pyrogenic intravascular administration set used to provide access for the administration of fluids to a patient's vascular system.

The specific lot number identified in the recall is 4719728. The distribution pattern includes nationwide distribution in the US and specific countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare providers and consumers should check their inventory for this specific lot number and stop using the affected sets.

The recalled product

Product
124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034959(17)250201(30)25(10)4719728. The Intravascular Administration Set is a single use, sterile, n
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:4719728.

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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