Arrow JACC Medical Device Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling Arrow JACC devices with Chloraguard Technology due to an incorrect expiration date 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: 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 Arrow JACC devices with Chloraguard Technology (Product Code: JR 42541 HPHNM) because the product displays an incorrect expiration date. The recall involves a specific batch identified by the code 13F17F0098.
The agency classification for this recall is Class II. The source text indicates that the primary issue is a labeling error regarding the expiration date, rather than a defect in the device's physical structure or function.
Consumers and healthcare providers who have this specific product should check the expiration date and batch code. If the product matches the recalled batch, they should stop using it and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 1
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: 13F17F0098
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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