Arrowg+ard Blue Advance PICC Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 450 units of Arrowg+ard Blue Advance PICC devices due to incorrect expiration dates.
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 involves a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling 450 units of Arrowg+ard Blue Advance PICC devices (Product Code: CDC45541HPK1A). The recall was initiated because the product was labeled with an incorrect expiration date.
The affected devices are identified by the following batch codes: 23F17K0359, 23F18C0027, and 23R17K0359. The recall is classified as Class II by the U.S. Food and Drug Administration.
The source text does not specify the geographic distribution of the affected units or provide specific instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 450
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 (3)
- Batch Code: 23F17K0359
- 23F18C0027
- 23R17K0359
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 36 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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