ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood tubing sets because they are labeled as not containing DEHP, but 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 or injuries, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 140-inch Y-Type Blood Sets with 170 Micron Filters. The recall is due to a labeling error where the devices are 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 3328076, 3343706, 3351028, 3359075, 3364783, 3373275, 3387655, 3391953, 3396191, 3408969, and 3423458. The product was distributed nationwide in the United States and in Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.
Healthcare facilities and consumers should stop using these specific blood sets and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, 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 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 (12)
- Item Number B9772
- Lot Number 3328076
- 3343706
- 3351028
- 3359075
- 3364783
- 3373275
- 3387655
- 3391953
- 3396191
- 3408969
- 3423458
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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