Recall Z-0162-2011

LifeCell Corporation · initiated September 13, 2010

Terminated

Product

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

Codes / lots: B27815A, Item no 663002, Graft Jacket Xpress 2011-01, Optiva IV Catheter Expiration 2010-05 B28417A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B28419A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B28420A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B29170A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29172A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29174A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29381A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B29923A, Item no 663002, Graft Jacket Xpress 2011-03, Optiva IV Catheter Expiration 2010-05 B29927A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30035A, Item no 663002, Graft Jacket Xpress 2011-06, Optiva IV Catheter Expiration 2010-05 B30036A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30039A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05…

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.

FDA-determined cause: Labeling mix-ups

Action taken

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

Details

Recall number: Z-0162-2011
Initiated: September 13, 2010
Posted by FDA: October 28, 2010
Terminated: August 17, 2012
Product code: KGZ – Accessories, Catheter
Quantity: 1507 kits
Distribution: Nationwide Distribution: USA, to distributor in TN
Recalling firm: LifeCell Corporation, Somerville, NJ

Official FDA recall record