Data Foundry

Medical device recalls 2015

ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit — Class II medical device recall Z-1082-2015

Terminated recall by Arrow International Inc, reported 2015-02-18, distributed nationwide. Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visib

Recall numberZ-1082-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArrow International Inc, Reading, PA, United States
Recall initiated2015-01-02
Classified2015-02-10
Reported by FDA2015-02-18
Terminated2016-10-25
DistributedNationwide (US)
Quantity1,195
Reason classesforeign material
Lot numbers23F14A0063

Product

ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.

Reason for recall

Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

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-1082-2015. 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.