Arrow PICC Kit Recalled for Incorrect Expiration Date Labeling
Arrow International Inc. is recalling 105 units of Arrow PICC Kits due to incorrect expiration dates on the packaging.
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: This is a minor labeling error (incorrect expiration date) with no reported illnesses or injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Arrow International Inc. is recalling 105 units of Arrow PICC Kits, Product Code ASK 45541 LVH1, with Batch Code 23F18E0221. The recall was initiated because the product was labeled with an incorrect expiration date.
The affected products were distributed nationwide and to foreign markets. The source text does not specify the exact number of units distributed in each region or the specific foreign countries involved.
Consumers and healthcare facilities should stop using the affected PICC Kits and contact Arrow International Inc. for instructions on how to return the product or obtain a replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Arrow¿ PICC Kit Product Code: ASK 45541 LVH1
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — PICC Kit
- Hazard
- Affected units
- 105
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: 23F18E0221
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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