Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2614-2018·Announced 2018-08-15

ICU Medical Recalls Lopez Valve Devices Due to DEHP Labeling Error

ICU Medical is recalling Lopez Valve, Sterile blood tubing accessories because some units were incorrectly labeled as not containing DEHP, though they may contain small amounts.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error regarding DEHP content without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of Lopez Valve, Sterile blood tubing accessories. These single-use, sterile devices are intended for needle-free withdrawal of blood as an adjunct to blood tubing sets or venipuncture devices.

The recall was initiated because some devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. The affected units are identified by Item Number 081-M9000R and specific lot numbers: 3333002, 3352936, 3365931, 3380288, 3402532, and 3413037.

The devices were distributed nationwide in the United States to 29 states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected units and contact ICU Medical for instructions on return or disposal.

The recalled product

Product: Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Tubing Accessory
Hazard: mis-labeling
dehp-exposure
Affected units: 160,016

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 (7)

Item Number 081-M9000R
Lot Number 3333002
3352936
3365931
3380288
3402532
3413037

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Part of a larger recall action

This product is one of 53 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 53 products in this recall →

Same manufacturer · ICU Medical, Inc.

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