CareFusion Recalls VersaSafe Extension Sets Due to Adhesive Defect
CareFusion is recalling VersaSafe Extension Sets because excessive adhesive may prevent the male spin collar from operating as intended.
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, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CareFusion 303, Inc. is recalling the VersaSafe Extension Intravascular Administration Set, Model No. 21000M-007. The recall involves 3,500 units from Lot No. 13066550 that were distributed nationwide.
The product is being recalled because it may have excessive adhesive, which will prevent the male spin collar from operating as intended. This defect could impact the functionality of the medical device.
Healthcare facilities and consumers should stop using the affected units and contact CareFusion for further instructions or a replacement.
The recalled product
- Product
- VersaSafe Extension Set, Model No. 21000M-007
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 3,500
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 No. 13066550
Distribution
Distributed nationwide across the United States.
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