ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling blood tubing sets labeled as DEHP-free because they 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 indicates the issue is a labeling error regarding DEHP content without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ICU Medical, Inc. is recalling specific blood tubing sets that are incorrectly labeled as "Does not contain DEHP." The recalled devices are the 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave, Check Valve, Y-Connector, Rotating Luer, Sterile. The recall is due to a labeling error where the product may actually contain small amounts of DEHP despite the label stating otherwise.
The affected product is identified by Item Number 061-C6033 and Lot Number 3364588. A total of 160,016 units were distributed worldwide, including nationwide distribution in the United States to specific states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The devices are single-use, sterile, non-pyrogenic accessories intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
This is an FDA Class II recall. No illnesses or injuries have been reported in the source text. Users should verify the item and lot numbers on their devices against the recalled information and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, 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
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Blood Tubing
- 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 061-C6033
- Lot Number 3364588
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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