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Recall Observatory FDA recall evidence

Device 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.

Z-1082-2015

January 02, 2015

Class II

Product summary

Firm
Arrow International Inc
Event
Event 70175
Status
Terminated
Classification
Class II
Quantity
1195
Official record key
device-enforcement:Z-1082-2015

Official wording

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

Code information: product number CDC-42802-P1A, lot number 23F14A0063

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign material