ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they 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 the presence of small amounts of DEHP without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 98-inch Y-Type Blood Sets with 170 Micron Filters, Hand Pumps, and Clave Connectors. The recall involves specific lots identified by item number Z3465 and lot numbers 72-139-HE, 73-646-HE, 75-267-JW, and 75-437-JW. These devices are single-use, sterile, non-pyrogenic accessories intended for needle-free withdrawal of blood.
The recall was initiated because some of the devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. This labeling discrepancy is the primary reason for the recall action.
The affected products were distributed nationwide in the United States to specific states including Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia. The products were also distributed to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should check their inventory for the specific item and lot numbers listed and stop using the affected devices.
The recalled product
- Product
- 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, 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 ven
- 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 (5)
- Item Number Z3465
- Lot Number 72-139-HE
- 73-646-HE
- 75-267-JW
- 75-437-JW
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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