ICU Medical Recalls Spiros Transfer Sets Due to Molding Defect
ICU Medical is recalling Spiros transfer sets due to a molding defect that may cause leakage in the inactivated position.
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: The recall involves a medical device with a defect that could lead to fluid leakage, representing a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF 011-H3597 Spiros transfer sets. These medical devices are used to provide access for the administration of fluids from a container to a patient's vascular system.
The recall is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position of the spinning and non-spinning Spiros male luers. The affected product is identified by REF 011-H3597 and Lot Number 5125225.
The product was distributed nationwide in the United States and in several international countries, including Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. Healthcare providers and consumers should check their inventory for the specific lot number and discontinue use if found.
The recalled product
- Product
- REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - 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 inserted…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
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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