ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 85-inch Y-Type Blood Sets because some units are 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 describes a labeling error regarding DEHP content without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 85" (216 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, Clave, and Rotating Luer. The recall is due to a labeling error where some devices are marked as "Does not contain DEHP" despite the possibility that the product contains small amounts of DEHP.
The affected blood tubing accessories are single-use, sterile, non-pyrogenic devices intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood. The recall covers specific lot numbers: 3332396, 3338446, 3347144, 3371146, 3374292, 3405438, 3423451, and 3426308, under Item Number B9405.
The devices were distributed nationwide in the United States to 28 states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and consumers should stop using the affected lots and contact ICU Medical for further instructions.
The recalled product
- Product
- 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 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-fr
- 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 (9)
- Item Number B9405
- Lot Number 3332396
- 3338446
- 3347144
- 3371146
- 3374292
- 3405438
- 3423451
- 3426308
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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