Arrow Epidural Needle Component Recalled for Missing Shelf Life Labeling
Arrow International Inc. is recalling 63,022 units of ARROW Epidural Needle Components because the product labeling does not specify the 5-year shelf life.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and labeling issue (missing shelf life) without reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation problems.
Plain-English summary
Arrow International Inc. is recalling 63,022 units of ARROW Epidural Needle Components (product number AN-05501). The recall was initiated because the product labeling does not specify the 5-year shelf life of the product.
The affected products were distributed in the United States, Canada, and Mexico. The recall includes specific lot numbers, which are listed in the agency's official records.
Consumers and healthcare providers should check their inventory for the affected product number and lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 63,022
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 (20)
- Product number AN-05501
- Lot numbers: 23F13J0530
- RF2108954
- RF6127264
- RF8045530
- RF0021370
- RF3014600
- RF6127624
- RF8070744
- RF0035171
- RF3026989
- RF7031498
- RF8083748
- RF0050648
- RF5084669
- RF7043570
- RF8096949
- RF0075647
- RF5094931
- RF7088907
Distribution
Distributed nationwide across the United States.
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