Arrow VPS Access Kit Recalled for Missing Dressing Information
Arrow International is recalling VPS Access Kits because they lack required information regarding the included 3M Tegaderm CHG dressing.
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 explicitly states the issue is missing information and does not report any illnesses or injuries. Per the rubric, this fits the criteria for a moderate severity score (2) as a labeling/documentation issue without reported harm.
Plain-English summary
Arrow International is recalling 3,918 units of the Arrow VPS Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters. The recall was initiated because the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing included in the package.
The affected products were distributed in the United States to the state of North Carolina. The recall involves specific lot numbers, including 23F15L0593, 23F16A0300, and 23F16B0028, among others. The device listing number is D156491.
Customers who received the affected product have been notified by Arrow International. The source text does not specify further instructions for consumers or report any illnesses or injuries associated with the missing information.
The recalled product
- Product
- Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
- Manufacturer
- Arrow International Inc
- Affected units
- 3,918
Distribution
Distributed in 1 state:
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