Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue… — Class II medical device recall Z-1119-2019
Terminated recall by Arrow International Inc, reported 2019-04-17, distributed in FL, NC. The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming
| Recall number | Z-1119-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2019-01-10 |
| Classified | 2019-04-10 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-06-04 |
| Distributed | FL, NC |
| Quantity | 45 eaches |
| UPC / GTIN / UDI-DI | 00801902015396 |
| Lot numbers | 71F15D1461, 71F15J1055, 71F15K0223, 71F18A1856 |
Product
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Reason for recall
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
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-1119-2019. 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.