1) Introducer Kit with Integral Hemostasis Valve/Side Port — Class II medical device recall Z-2329-2017
Terminated recall by Arrow International Inc, reported 2017-06-21, distributed nationwide. Arrow International is recalling the affected product because the packaging may not be completely sealed, whic
| Recall number | Z-2329-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2017-05-09 |
| Classified | 2017-06-12 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | sterility |
Product
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Reason for recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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-2329-2017. 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.