ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood 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 and involves a minor labeling error regarding DEHP content without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 112" Y-Type Blood Sets with 170 Micron Filter, Hand Pump, Pre-Slit Port, and Rotating Luer. 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 single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood. The recall covers specific lot numbers including 3332350, 3338393, and 3343644, among others. Distribution was worldwide, including nationwide distribution in the United States and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.
Healthcare providers and consumers should stop using the affected devices and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, 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-fre
- 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 (14)
- Item Number B3000-75
- Lot Number 3332350
- 3338393
- 3343644
- 3352549
- 3364662
- 3365599
- 3373893
- 3378376
- 3387536
- 3405268
- 3426053
- 3428573
- 3429586
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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