TriVascular brand Fill Polymer Kit recall
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory…
Why was TriVascular brand Fill Polymer Kit recalled?
Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
The following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01, FF051012-01
- Product
- TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory…
- Recalling firm
- Trivascular, Inc
- Quantity
- 41 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Belgium, Cyprus, Italy, Spain, Switzerland and Turkey. TriVascular stated that no purchased devices are in hospital inventory in Europe or the U.S.
- Recall date
- November 21, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)