Arrow AGB+ Multi-Lumen CVC Kit — Class II medical device recall Z-0468-2019
Terminated recall by Arrow International Inc, reported 2018-11-21, distributed nationwide. The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper la
| Recall number | Z-0468-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2018-09-21 |
| Classified | 2018-11-14 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-09-23 |
| Distributed | Nationwide (US) |
| Quantity | 3,640 |
| Reason classes | labeling |
| Lot numbers | 13F17E0685, 13F17F0562, 13F17H0141, 13F17K0340, 13F18B0119, 13R17E0685 |
Product
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
Reason for recall
The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .
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-0468-2019. 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.