IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labe
FDA device recall Z-0162-2011 · posted 2010-10-28 · Terminated
Recall details
- Recalling firm
- LifeCell Corporation
- 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.
- Action taken
- Lifecell Corporation, Branchburg, NJ initiated a recall to their distributor Wright Medical Technology, Arlington, TN on 9/13/2010.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KGZ
- Quantity affected
- 1507 kits
- Distribution
- Nationwide Distribution: USA, to distributor in TN
- Date initiated
- 2010-09-13
- Date posted
- 2010-10-28
- Date terminated
- 2012-08-17
- Location
- Somerville, NJ
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