ICU Medical Blood Set Recall for Incorrect DEHP Labeling
ICU Medical is recalling blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.
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 hazard is a labeling error regarding DEHP content rather than a structural defect or reported injury, fitting the criteria for moderate severity.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 32-inch blood sets with CLAVE Connectors. The affected devices are single-use, sterile blood tubing accessories intended for needle-free blood withdrawal. The recall is due to a labeling error where the devices were marked as "Does not contain DEHP" even though the product may contain small amounts of DEHP.
The affected product is Item Number 061-C6028, Lot Number 3414382. Distribution was worldwide, including nationwide distribution in the United States to 28 states and specific countries including Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.
This is a Class II recall. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, 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 with
- 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 061-C6028
- Lot Number 3414382
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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