Arrow PICC with Chloraguard Technology Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 578 units of Arrow PICC with Chloraguard Technology due to 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, and the hazard is a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 578 units of Arrow PICC with Chloraguard Technology (Product Code: PR 45552 HPHNL). The recall was initiated because the product was labeled with an incorrect expiration date.
The affected units are identified by batch codes 13F17E0017, 13F17F0523, and 13R17F0523. The products were distributed nationwide and to foreign locations.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions.
The recalled product
- Product
- Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 578
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: 13F17E0017
- 13F17F0523
- 13R17F0523
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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