Arrow International Recalls Cannon II Plus Replacement Hub Sets for Labeling Error
Arrow International Inc is recalling Cannon II Plus Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.
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 source text describes a labeling error (incorrect expiration date) with a theoretical risk of infection rather than reported injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling specific lots of Cannon II Plus Replacement Hub Sets. The product is indicated for use in the replacement of a damaged Cannon II Plus hub connection assembly. The recall involves product code CAR-02400, specifically lot numbers 13F19J0153 and 23F17H0547. The affected products were distributed worldwide.
The recall was initiated because the lidstock states the incorrect expiration date for the product. This labeling error could result in the use of a device that is expired. Using an expired device could potentially lead to an increased risk of infection or other complications, as the sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the recalling firm, Arrow International Inc.
The recalled product
- Product
- Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
- 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)
- Product Code: CAR-02400 Lot #: 13F19J0153 and 23F17H0547
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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