Catheter Hemostasis Valve For use with — Class II medical device recall Z-1957-2018
Terminated recall by Arrow International Inc, reported 2018-06-06, distributed nationwide. Product sterility may be compromised due to unsealed packaging.
| Recall number | Z-1957-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2018-04-11 |
| Classified | 2018-05-30 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2020-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, EC, ES, FR, GB, GR, HK, ID, IE, IT, JP, KR, NL, NZ, PA, PH, PL, RO, SA, SE, SG, SI, TH, TT, ZA |
| Quantity | 416,055 products |
| Reason classes | sterility |
| Lot numbers | 13F17C0232, 13F17G0194, 13F17H0047, 13F17J0083 |
Product
Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
Reason for recall
Product sterility may be compromised due to unsealed packaging.
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-1957-2018. 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.