ICU Medical Lopez Valve Recall for Incorrect DEHP Labeling
ICU Medical is recalling Lopez Valves with Red Caps because they were labeled as DEHP-free but may contain small amounts of DEHP.
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 or injuries, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of Lopez Valve w/Red Cap, Sterile. These are single-use, sterile, non-pyrogenic blood tubing accessories with CLAVE Connectors intended for needle-free withdrawal of blood. The recall is due to a labeling error where some devices were marked as "Does not contain DEHP" even though the product may contain small amounts of DEHP.
The affected devices are Item Number 081-M9000R, with Lot Numbers 3333003, 3352935, 3365932, 3383035, 3402533, and 3413038. The products were distributed nationwide in the United States to specific states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.
This is an FDA Class II recall. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Patients who have received these devices should consult their healthcare provider if they have concerns regarding DEHP exposure.
The recalled product
- Product
- Lopez Valve¿ w/Red Cap, 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 3333003
- 3352935
- 3365932
- 3383035
- 3402533
- 3413038
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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