Agency classClass IIOur severity:High FDA (Devices)·Z-0248-2021·Announced 2020-10-28

ICU Medical Recalls ChemoClave Sets Due to Potential Seal Defect

ICU Medical is recalling ChemoClave needle-free transfer sets because a manufacturing defect may prevent a proper seal, potentially allowing contaminants to enter the system.

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 defect that could allow hazardous drug exposure or contamination, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of ChemoClave needle-free Closed System Transfer Devices (CSTDs). The recall involves 6.5-inch extension sets with Clave Clear, Clave 4-Way Stopcock, and Spiros Red Cap components. The total quantity of affected products is 304,735 units.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The ChemoClave is designed to mechanically prohibit the transfer of environmental contaminants, including bacterial and airborne contaminants, into the system and the escape of drug or vapor concentrations outside the system. A failure to seal properly could compromise this safety function.

The affected products were distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for further instructions.

The recalled product

Product: 6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion / IV Sets
Hazard: contamination
seal-failure

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:4493149.

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 →

Same manufacturer · ICU Medical, Inc.

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Same hazard · contamination