ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood set units because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
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 identifies the issue as a labeling error regarding DEHP content without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling error.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 185 cm (73") Blood Sets with 200 Micron Filter, Clave Connector, and Rotating Luer. The recall is due to a labeling error where the devices were marked as "Does not contain DEHP" despite the possibility that the product contains small amounts of DEHP.
The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood. The recall covers specific lot numbers 3408801, 3408803, and 3419007 under Item Number 011-C6031.
Distribution was worldwide, including nationwide distribution in the United States to 29 states and international distribution to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and consumers should stop using these specific lots and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- 185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, 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 b
- 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 (4)
- Item Number 011-C6031
- Lot Number 3408801
- 3408803
- 3419007
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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