ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 119-inch blood sets labeled as DEHP-free because they may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.
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 specific hazard is a minor labeling error regarding DEHP content without reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 119-inch Blood Sets with 200 Micron Filter, Clave Connector, and Rotating Luer. The devices are single-use, sterile, non-pyrogenic accessories 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. This constitutes a labeling error regarding the chemical composition of the device.
The affected product is Item Number 011-C6000, Lot Number 3422869. Distribution was worldwide, including nationwide distribution in the US to specific states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Users should contact the manufacturer for further instructions.
The recalled product
- Product
- 119" 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 blood.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- 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 (2)
- Item Number 011-C6000
- Lot Number 3422869
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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