The Recall Desk
SevereFDA (Devices)·Z-0258-2021·Announced 2020-10-28

ICU Medical Recalls Burette Sets Due to Potential Manufacturing Defect

ICU Medical is recalling specific lots of 112-inch burette sets because a manufacturing defect may prevent a proper seal with the NanoClave spike.

What this means for you

Illness, injury, or structural failure has been reported. 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, which corresponds to a 'Severe' severity score under the rubric, as it involves a defect that could lead to serious adverse health consequences.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 112" (284 cm) 60 Drop 150ml Burette Sets. The recall involves a total of 304,735 units distributed worldwide, including in the United States and various international countries such as Canada, Germany, and Japan.

The recall was initiated due to the identification of a potential manufacturing defect on the internal surface of the NanoClave component within the affected sets. This defect may inhibit a proper seal with the NanoClave spike. The agency has classified this recall as Class II.

Healthcare facilities and consumers should stop using the affected products immediately. The specific lot number is 4727501. Users should check their inventory for this lot number and contact the manufacturer or their supplier for instructions on how to return or dispose of the recalled devices.

The recalled product

Product
112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709079127(17)250201(30)25(10)4727501. The Intravascular Administration Set is a
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Sets
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:4727501.

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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