ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 116-inch Y-Type Blood Sets because they were 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. Per the rubric, minor labeling errors or low-risk issues without reported harm fall under Moderate severity.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 116" (295 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, 3 MicroClave, 2 Ext, Rotating Luer, Sterile. The specific item number is Z4088 and the lot number is 3429743. These devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood.
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 is a labeling discrepancy regarding the presence of a chemical component in the medical device.
The affected products were distributed worldwide, including nationwide distribution in the United States to specific states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Users of these devices should check their inventory for the specific item and lot numbers listed above. If found, they should stop using the devices and contact ICU Medical for further instructions.
The recalled product
- Product
- 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, 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 device
- 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 (2)
- Item Number Z4088
- Lot Number 3429743
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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