Recall Z-0162-2011 ยท KGZ Accessories, Catheter
LifeCell Corporation
IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.
| Date | Oct 28, 2010 (initiated Sep 13, 2010) |
| Status | Terminated |
| Reason | 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 | Labeling mix-ups |
| Action | Lifecell Corporation, Branchburg, NJ initiated a recall to their distributor Wright Medical Technology, Arlington, TN on 9/13/2010. |
| Quantity | 1507 kits |
| Distribution | Nationwide Distribution: USA, to distributor in TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.