Arrow Single Shot Epidural Anesthesia Kit — Class II medical device recall Z-2801-2020
Terminated recall by Arrow International Inc, reported 2020-08-19. The lidstock states the incorrect expiration date for the product. This issue could result in use of a device
| Recall number | Z-2801-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2020-07-06 |
| Classified | 2020-08-13 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2021-11-05 |
| Reason classes | labeling, sterility |
| Lot numbers | 13F17J0230 |
Product
Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
Reason for recall
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
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-2801-2020. 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.