Percutaneous Sheath Introducer Kit for use with 7 — Class II medical device recall Z-2576-2018
Terminated recall by Arrow International Inc, reported 2018-08-08, distributed in PR. Product contains dry natural rubber latex. Label states Latex Free.
| Recall number | Z-2576-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2018-05-23 |
| Classified | 2018-07-30 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2020-05-20 |
| Distributed | PR |
| Quantity | 60 units |
| Reason classes | labeling |
| Lot numbers | 13F18A0037 |
| Model numbers | ES-09807 |
Product
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Reason for recall
Product contains dry natural rubber latex. Label states Latex Free.
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-2576-2018. 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.