Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
- Company
- Guidant Cardiac Surgery
- Recall Initiated
- December 1, 2006
- Posted
- March 16, 2007
- Terminated
- December 4, 2007
- Recall Number
- Z-0612-2007
- Quantity
- 57,691 units distributed total
- Firm Location
- Santa Clara, CA
Reason for Recall
Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
Distribution
Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.
Lot / Code Info
All products with expiry dates of June 2008, lot codes ranging from 4120281 to 6102381. See Below: 4120281 5020781 5051381 5062181 5091481 5110182 6013181 6040581 6062481 6091881 6101881 4120681 5021481 5052381 5072881 5092781 5110381 6020681 6050181 6070581 6091981 6101882 4121581 5031681 5052382 5081081 5092782 5110481 6020682 6050681 6081781 6092581 6102381 5010681 5032181 5061581 5081681 5101881 5120181 6022181 6051881 6081782 6092582 5011881 5040681 5061681 5081781 5101981 5120281 6030681 6052081 6081881 6101181 5012881 5041881 5061781 5081782 5101982 6010481 6030781 6060981 6083081 6101681 5020381 5050281 5062081 5081881 5110181 6011981 6040481 6061981 6083181 6101682
Root Cause
Other
Action Taken
The firm has issued by FedEx letters dated 12/1/2006, to all consignees who received the product in the US, and has also informed their foreign distributors in the same manner on December 4, 2006. The firm''s field representatives were notified via teleconference on December 1, 2006. A hard copy of the notice was delivered to field reps on December 4 as well.