Arrow JACC Medical Device Recalled for Incorrect Expiration Date Labeling
Arrow International Inc. is recalling 9 units of Arrow JACC with Chloraguard Technology due to incorrect expiration dates 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, but the specific defect is a minor labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc. is recalling 9 units of Arrow JACC with Chloraguard Technology, Product Code JR 42063 HPHNM. The recall was initiated because the product was labeled with an incorrect expiration date.
The affected units are identified by Batch Codes 13F17C0327 and 13R17C0327. The distribution pattern is listed as nationwide and foreign, though specific geographic details are not provided in the source text.
Consumers and healthcare providers should stop using the affected products and contact Arrow International Inc. for further instructions or a return.
The recalled product
- Product
- Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 9
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 (2)
- Batch Code: 13F17C0327
- 13R17C0327
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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