LifeCell Corporation

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

General and Plastic Surgery Devices

1

No

Nationwide Distribution: USA, to distributor in TN

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

Lot Numbers: B06E02E; Exp 3/2008; B06E02F, Exp. 3/2008; B07C29B, Exp 2/2009; B07E14E, Exp 3/2009; B07G24B, Exp 5/2009; B07G24C, Exp 5/2009; B07G24E, Exp. 5/2009; and B07G24F, Exp 5/2009.

Orthopedic Devices

2

Yes

All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.

AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine

Lot Numbers: B07F25I; Exp 4/2009; B07F25J: Exp 4/2009; and B07425H; Exp 3/2009.

Orthopedic Devices

2

Yes

All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.

AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine

Lot S10624, Exp. 2011-04.

General and Plastic Surgery Devices

2

Yes

Nationwide Distribution: USA, including the states of AZ, DC, FL, GA, ID, IL, KY, LA, MO, NC, OH, OK, OR, TX, WA, and WI.

Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. || 8 cm x 8 cm || Packaged in an inner foil pouch inside outer foil pouch tertiary carton. || LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876 || Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. It is intended for single patient one time use.