Arrow International Recalls NextStep Retrograde Replacement Hub Set Due to Labeling Error
Arrow International is recalling NextStep Retrograde 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. The hazard is a labeling error (incorrect expiration date) that could lead to the use of an expired device, posing a potential risk of infection, but no injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling the NextStep Retrograde Replacement Hub Set, product code NRH-15192, lot number 13F19H0454. The product is indicated for use in the replacement of a damaged NextStep Retrograde hub connection assembly. The recall is due to a labeling error where the lidstock states the incorrect expiration date for the product.
The incorrect expiration date 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.
The product was distributed worldwide. Users should check their inventory for the specific product code and lot number listed above. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor.
The recalled product
- Product
- NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde 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: NRH-15192 Lot #: 13F19H0454
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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