Arrow PICC with Chloraguard Technology Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling Arrow PICC with Chloraguard Technology due to an incorrect expiration date 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 due to a labeling error (incorrect expiration date), which fits the rubric criteria for minor labeling errors or low-risk issues.
Plain-English summary
Arrow International Inc. is recalling Arrow PICC with Chloraguard Technology (Product Code: PR 45552 HPHNM) because the product was labeled with an incorrect expiration date. The recall involves 4,345 units distributed nationwide and to foreign markets.
The specific batch codes affected by this recall are 13F17B0178, 13F17C0469, 13F17E0120, 13F17G0412, 13F17H0393, and 13F18A0194. This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should check their inventory for these specific batch codes and stop using the affected products. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding the recalled items.
The recalled product
- Product
- Arrow¿ PICC with Chlorag+ard¿ Technology Product Code:PR 45552 HPHNM
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 4,345
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 (6)
- Batch Code: 13F17B0178
- 13F17C0469
- 13F17E0120
- 13F17G0412
- 13F17H0393
- 13F18A0194
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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