Arrow PICC Recall Due to Incorrect Expiration Date Labeling
Arrow International Inc is recalling 108 units of Arrow PICC with Chloraguard Technology because the product was labeled with an incorrect expiration date.
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 specific defect is a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Arrow International Inc is recalling 108 units of Arrow PICC with Chloraguard Technology (Product Code: CDA 45041 HPK1A). The recall was initiated because the product was labeled with an incorrect expiration date.
The affected units are identified by batch codes 23F17J0249 and 23F18E0349. The products were distributed nationwide and to foreign locations.
Consumers and healthcare providers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 108
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 (2)
- Batch Code:23F17J0249
- 23F18E0349
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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