The Recall Desk
HighFDA (Devices)·Z-0256-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of intravascular administration 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 involves a medical device with a defect that may compromise the sterile seal, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 149-inch intravascular administration sets. The recall involves a total of 304,735 units distributed nationwide in the United States and in several international countries, including Canada, Mexico, and various nations in Europe and Asia.

The recall was initiated due to 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 affected products are identified by lot numbers 4711277 and 4719610.

Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected sets. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;(01)10887709074696(17)250201(30)25(10)4719610. . The Intravascular Administration Set is a singl
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 (2)

  • Lot Number:4711277
  • 4719610.

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 →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · seal defect

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