ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 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 and involves a minor labeling error regarding DEHP content without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 94-inch (239 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, and Rotating Luer. The recalled devices are sterile, single-use blood tubing accessories with CLAVE Connectors intended for needle-free withdrawal of blood. The recall is due to a labeling error where some devices were marked as "Does not contain DEHP" despite the possibility that the product contains small amounts of DEHP.
The affected products are Item Number B30095 and include Lot Numbers 3352422, 3384297, 3391696, 3405273, 3416461, and 3432479. These devices were distributed nationwide in the United States to specific states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The recall is classified as Class II by the FDA.
Healthcare facilities and distributors should stop using the affected blood sets and contact ICU Medical for further instructions. Patients who have received blood transfusions using these specific devices should consult their healthcare provider if they have concerns regarding the labeling discrepancy.
The recalled product
- Product
- 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 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-free withd
- 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 (7)
- Item Number B30095
- Lot Number 3352422
- 3384297
- 3391696
- 3405273
- 3416461
- 3432479
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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