ICU Medical Recalls Sprios Male Luer Administration Sets Due to Leakage
ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.
What this means for you
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: The recall involves a medical device with a defect that poses a risk of harm (leakage) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Sprios male luer administration sets, including both spinning and non-spinning variants. The recall is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position. The affected product is identified by Reference 011-H2864-HSR and Lot Number 5142887.
These administration sets are used to provide access for the administration of fluids from a container to a patient's vascular system. The recall covers products distributed nationwide in the United States and internationally in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.
Healthcare facilities and consumers should check their inventory for the specific reference and lot numbers listed in this notice. If the affected product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserte
- Manufacturer
- ICU Medical, Inc.
Distribution
Part of a larger recall action
This product is one of 26 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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