Arrow Single Shot Epidural Anesthesia Kit Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling specific lots of Single Shot Epidural Anesthesia Kits 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 expired devices, posing a potential risk of infection, but no illnesses or injuries are reported in the source text.
Plain-English summary
Arrow International Inc. is recalling the Arrow Single Shot Epidural Anesthesia Kit, specifically Product Code AK-03000-S and Lot # 13F17J0230. The recall was initiated because the lidstock for these kits states an incorrect expiration date. This labeling error could result in the use of a device that is expired, which could potentially lead to an increased risk of infection or other complications.
The source text notes that the sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date. The affected products were distributed worldwide.
Healthcare providers and consumers should check their inventory for the specific product code and lot number listed above. If the product matches the recalled lot, it should not be used. Users should contact Arrow International Inc. for further instructions on how to return or dispose of the affected kits.
The recalled product
- Product
- Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Anesthesia Kits
- 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: AK-03000-S Lot #: 13F17J0230
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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