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.
What this means for you
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.
- 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
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.
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