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Terminated

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.

FDA Recall Z-1082-2015 · Posted 2015-02-10

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2015-01-02
Date Terminated2016-10-25
Product Quantity1195

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.

Firm Action

An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.

Root Cause

Process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERArrow International, Inc. · 2007-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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