ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 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, which typically corresponds to a moderate severity level. The hazard involves a labeling error regarding DEHP content, which is a minor labeling issue rather than a direct structural defect or high-risk pathogen.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 108" 20 Drop Blood Sets with CLAVE Connectors. The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories 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 products are Item Number 011-C6047, with Lot Numbers 3393617 and 3419260. Distribution was worldwide, including nationwide distribution in the United States to specific states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.
Consumers and healthcare facilities should check their inventory for the specific item and lot numbers listed above. If the devices match the recalled description, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, 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 venipunctu
- 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 (3)
- Item Number 011-C6047
- Lot Number 3393617
- 3419260
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.
See all 53 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02