ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 105-inch Y-Type Blood Sets because some 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, but the source text describes a labeling error regarding DEHP content without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues where harm has not been reported.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 105" (267 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave Clear, Rotating Luer, and 1 Extension. The affected devices are sterile, single-use blood tubing accessories intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
The recall was initiated because some devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. This labeling discrepancy affects the accuracy of the product's chemical composition information.
The affected lots are 3254697, 3296639, 3309836, and 3310605, under Item Number MRSB-105. The products were distributed nationwide in the United States to specific states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected devices and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an
- 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 MRSB-105
- Lot Number 3254697
- 3296639
- 3309836
- 3310605
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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