Arrow International Recalls PICC Sets with Incorrect Expiration Dates
Arrow International Inc is recalling PICC Sets (PR-35052-HPHNM) because the product lidstock contains the 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 involves a minor 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 PICC Sets, model PR-35052-HPHNM, due to a labeling error. The product lidstock contains the incorrect expiration date for the product.
The affected lot number is 13F18A0540. The recall is classified as Class II by the U.S. Food and Drug Administration. Distribution was nationwide and in foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.
Healthcare providers and consumers should stop using the affected PICC Sets and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- PICC Set- PR-35052-HPHNM
- Manufacturer
- Arrow International Inc
- Hazard
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)
- Lot Number: 13F18A0540
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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