ICU Medical Recalls Spiros Male Luer Extensions Due to Leakage
ICU Medical is recalling Spiros male luer extensions 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 risk-of-harm product (medical device for cytotoxic drugs) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Spiros male luer extensions, including both spinning and non-spinning models. The recall is due to a molding defect that creates a potential for small amounts of leakage when the device is in the inactivated position.
The affected product is identified by Reference CH3582 and Lot Number 5125197. These devices are used for the preparation and patient administration of cytotoxic medications. The recall covers worldwide distribution, including nationwide distribution in the United States and distribution in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.
Healthcare providers and facilities should stop using the affected lots immediately. Users should check their inventory for the specific reference and lot number listed in the recall notice and contact ICU Medical for further instructions on returns or replacements.
The recalled product
- Product
- REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Set
- 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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