ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling
ICU Medical is recalling 160,016 Y-Type Blood Sets because some were labeled as not containing DEHP, though they may contain small amounts.
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 the hazard involves a minor labeling error regarding DEHP content without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or labeling issues.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 140" (356 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, Removable 4-Way Stopcock, CLAVE Connector, Rotating Luer, and 2 Extensions. 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 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 Item Number B90065 with Lot Numbers 3328034, 3347256, 3364748, 3374222, and 3395260.
Distribution was worldwide, including nationwide distribution in the United States to specific states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and consumers should stop using the affected devices and contact ICU Medical for further instructions.
The recalled product
- Product
- 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 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 venip
- 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 (6)
- Item Number B90065
- Lot Number 3328034
- 3347256
- 3364748
- 3374222
- 3395260
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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