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Terminated

IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.

FDA Recall Z-0162-2011 · Posted 2010-10-28

Recalling FirmLifeCell Corporation
Recall StatusTerminated
Product CodeKGZ
Date Initiated2010-09-13
Date Terminated2012-08-17
Product Quantity1507 kits

Reason for Recall

Graft Jacket Xpress kits contain catheters that will expire or have already expired prior to the labeled expiration of the human tissue component of the product on the outer box.

Firm Action

Lifecell Corporation, Branchburg, NJ initiated a recall to their distributor Wright Medical Technology, Arlington, TN on 9/13/2010.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution: USA, to distributor in TN

Official Source

View FDA Recall →

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

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