ARROW Epidural Needle Component — Class II medical device recall Z-1080-2015
Terminated recall by Arrow International Inc, reported 2015-02-18, distributed nationwide. The product labeling does not specify the 5 year shelf life of the product.
| Recall number | Z-1080-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2015-01-05 |
| Classified | 2015-02-10 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2018-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 63,022 |
| Reason classes | labeling |
| Lot numbers | 23F13J0530, RF0021370, RF0035171, RF0050648, RF0075647, RF0092301, RF2021938, RF2044557, RF2058276, RF2083791, RF2108954, RF3014600, RF3026989, RF5084669, RF5094931, RF5106225, RF5118327, RF5120725, RF6081852, RF6092570, RF6127264, RF6127624, RF7031498, RF7043570, RF7088907, RF7090151, RF7102346, RF7113197, RF8018337, RF8020947, RF8045530, RF8070744, RF8083748, RF8096949, RF8123534, RF9015869, RF9030002, RF9071402, RF9098526, RF9113319 |
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.
Reason for recall
The product labeling does not specify the 5 year shelf life of the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1080-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.