ARROWg+ard Blue PLUS — Class II medical device recall Z-2263-2017
Terminated recall by Arrow International Inc, reported 2017-06-14, distributed nationwide. Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury f
| Recall number | Z-2263-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2017-03-20 |
| Classified | 2017-06-06 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2018-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 43,394 units |
Product
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusions of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blood/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
Reason for recall
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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-2263-2017. 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.