ICU Medical ChemoLock Closed System Transfer Device Packaging Recall
ICU Medical is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80) due to incorrect packaging and labeling of finished goods. Units were distributed in Illinois and Canada.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for packaging and labeling errors with no reported injuries, hospitalizations, or illnesses. This fits the 'minor labeling errors' criterion for Moderate severity, as the hazard is documentation-related rather than a functional device defect.
Plain-English summary
ICU Medical, Inc. is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80, Lot Number 13959938) because finished goods were incorrectly packaged and labeled.
The ChemoLock Closed System Transfer Device is designed to prevent the transfer of environmental contaminants and to help prevent needlestick injuries and exposure to cytotoxic medications during chemotherapy drug handling. The affected lot was distributed to healthcare facilities in Illinois and Canada.
Healthcare providers and facilities that have received units from this lot should verify the packaging and labeling against the product specifications. Contact ICU Medical for guidance on how to proceed, including information on replacement products.
The recalled product
- Product
- ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to…
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 6,000
Distribution
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