Arrow PICC Catheter Recalled for Incorrect Expiration Date Labeling
Arrow International Inc. is recalling 162 units of Arrowg+ard Blue Advance PICC catheters due to an incorrect expiration date printed on the product.
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 162 units of Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS Precision Stylet, Product Code CDC 44052 VPS2. The recall was initiated because the product was labeled with an incorrect expiration date.
The affected units are identified by Batch Code 23F18H0497. The recall is classified as Class II by the U.S. Food and Drug Administration. Distribution was nationwide and to foreign locations.
Healthcare facilities and consumers should stop using the affected products and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44052 VPS2
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 162
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)
- Batch Code: 23F18H0497
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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