FDA Medical Device Recalls (openFDA)
LifeCell Corporation: IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.
- Recall number
- Z-0162-2011
- Recalling firm
- LifeCell Corporation
- Product
- IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.
- Status
- Terminated
- Initiated
- 2010-09-13
- Posted
- 2010-10-28
- Terminated
- 2012-08-17
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGZ
- Firm FEI
- 1000306051
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28