ICU Medical Recalls ChemoLock Vial Spike Due to Potential Burr Particulate
ICU Medical is recalling one lot of ChemoLock Vial Spike devices due to a potential for containing burr particulate. The recall covers 2,050 units distributed in the US and internationally.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are classified as Critical (Score 5).
Plain-English summary
ICU Medical, Inc. is recalling one lot of ChemoLock Vial Spike, 20mm (REF CL-80S) devices. The recall is being conducted because there is a potential for the devices to contain burr particulate. The ChemoLock Closed System Drug Transfer Device is designed to prevent the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.
The recall involves 2,050 units from Lot Number 3757712. These products were distributed in the United States to the states of Ohio, Florida, Iowa, California, Pennsylvania, Illinois, and Virginia. The products were also distributed internationally to Austria, China (Taiwan), Ireland, Italy, and Singapore.
The U.S. Food and Drug Administration has classified this recall as Class I. Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions.
The recalled product
- Product
- icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Drug Delivery
- Hazard
- Affected units
- 2,050
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 (1)
- Lot Number 3757712
Distribution
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