Z-0162-2011

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

Name: Z-0162-2011 IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue...
Creator: LifeCell Corporation
Published: 2010-09-13
License: https://open.fda.gov/license/

LifeCell Corp / initiated 2010-09-13 / Terminated / root cause: labeling and UDI

FDA source

LifeCell Corporation began a recall of IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright on 2010-09-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0162-2011
Status: Terminated
Initiated: 2010-09-13
Posted: 2010-10-28
Terminated: 2012-08-17
Recalling firm: LifeCell Corp
Product: IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.
Product code: KGZ Accessories, Catheter
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Lifecell Corporation, Branchburg, NJ initiated a recall to their distributor Wright Medical Technology, Arlington, TN on 9/13/2010.
Quantity in commerce: 1507 kits
Distribution: Nationwide Distribution: USA, to distributor in TN
Product codes and 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 B3004A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30043A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30701A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30702A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30703A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30708A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B31035A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B31036A, Item no 663002, Graft Jacket Xpress 2011-05, Optiva IV Catheter Expiration 2010-05 B31038A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B32670A, Item no 663002, Graft Jacket Xpress 2011-08, Optiva IV Catheter Expiration 2010-05 B32674A, Item no 663002, Graft Jacket Xpress 2011-08, Optiva IV Catheter Expiration 2010-05 B34512A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-05 B34514A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-06 B34516A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-05 B35329A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35334A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35336A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35623A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35624A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B35625A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B35627A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B37232A, Item no 663002, Graft Jacket Xpress 2012-06, Optiva IV Catheter Expiration 2011-06 B38274A, Item no 663002, Graft Jacket Xpress 2012-06, Optiva IV Catheter Expiration 2011-06 B5835A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B6092A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 C26276A, Item no 663002, Graft Jacket Xpress 2011-09, Optiva IV Catheter Expiration 2010-05 C6056A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 C6072A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 C6085A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05

Product code KGZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)