ICU Medical Recalls Spinning Spiros Closed Male Luer Components
ICU Medical is recalling specific Spinning Spiros components due to a molding defect that may cause leaks, risking fluid path contamination or exposure to hazardous medications.
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 defect that poses a risk of harm, including exposure to hazardous medications and fluid path contamination, but the source text does not report any specific injuries or illnesses.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Spinning Spiros Closed Male Luer, Add-On Set w/Spiros, and Bag Spike Adapter w/Spiros components. The recall involves approximately 37,000 units distributed nationwide in the United States and in numerous countries worldwide, including Italy, Belgium, the United Kingdom, Canada, Germany, and Australia.
The recall is due to a molding defect that may cause the spinning versions of the male luers to exhibit leaks. This fluid leakage could potentially lead to a delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions. The affected lot numbers are 4605119, 4726277, and 4727007.
The recalled product
- Product
- Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 37,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: 4605119
- 4726277
- 4727007
Distribution
Part of a larger recall action
This product is one of 13 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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