ICU Medical Recalls Oncology Kits Due to Molding Defect
ICU Medical is recalling specific lots of Oncology Kits with Spinning Spiros 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 could lead to fluid leakage, representing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF CL3946 Oncology Kits. These kits include a 5-inch (13 cm) Add-On Set with a ChemoLock Additive Port, Vented Cap, and Spinning Spiros with a Red Cap. The product is used to provide access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter.
The recall is being conducted due to a molding defect. This defect creates a potential for certain lots of spinning and non-spinning Sprios male luers to exhibit small amounts of leakage in the inactivated position.
The affected products were distributed worldwide, including nationwide distribution in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. The specific lot number identified in the recall is 5142959. Users should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle
- 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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