Catheter Connections Recalls DualCap IV Pole Strips Due to Packaging Seal Defect
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps because a packaging defect may compromise sterility. The recall affects 24,910 units distributed in four states.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential loss of sterility due to a packaging defect, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Catheter Connections, Inc. is recalling 24,910 units of DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves (REF 500-LB, Sterile). The recall is due to a potential improper packaging cap seal, which may render the sealed caps non-sterile.
The affected product, identified by Lot 1406509, was distributed in the United States to the states of Connecticut, Georgia, Maryland, and Pennsylvania. These caps are designed to disinfect needleless luer access valves and provide a physical barrier to contamination.
Healthcare facilities and consumers should stop using the affected units and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours…
- Manufacturer
- Catheter Connections, Inc.
- Category
- Medical Device — IV Accessories
- Affected units
- 24,910
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 1406509
Distribution
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