Data Foundry

Medical device recalls 2017

ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit — Class II medical device recall Z-2264-2017

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 numberZ-2264-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArrow International Inc, Reading, PA, United States
Recall initiated2017-03-20
Classified2017-06-06
Reported by FDA2017-06-14
Terminated2018-12-18
DistributedNationwide (US)
Quantity43,394 units

Product

ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation

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-2264-2017. 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.