ICU Medical Infusion Extension Set Recall Due to Connector Housing Gap
ICU Medical recalls 5.8 million infusion extension sets due to a manufacturing defect that creates a visible gap in the connector housing, potentially compromising device integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a manufacturing defect in a medical device affecting 5.8 million units with potential for harm to device function and patient safety, though no injuries or illnesses have been reported. Per the rubric, this constitutes a 'risk-of-harm product where injury has not yet been reported,' qualifying as High (score 3).
Plain-English summary
ICU Medical, Inc. is recalling approximately 5.8 million bifuse pressure infusion extension sets due to a manufacturing defect. The affected sets have a visible gap between the connector's top and bottom housing, which could compromise the seal and function of the device.
These extension sets were distributed throughout the United States (all states and territories) and internationally to multiple countries including Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
The recalled product
- Product
- 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 5,795,989
Distribution
Part of a larger recall action
This product is one of 6 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.
See all 6 products in this recall →Related recalls
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Similar recalls
- HighICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect
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- HighICU Medical Recalls NanoClave Pressure Infusion Extension Sets Due to Seal Defect
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