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Terminated

Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions

FDA Recall Z-2493-2010 · Posted 2010-09-25

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2010-07-29
Date Terminated2012-07-05
Product Quantity15

Reason for Recall

Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

Firm Action

The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.

Root Cause

Mixed-up of materials/components

Distribution Pattern

The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc. · 2000-03-08

Official Source

View FDA Recall →

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

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