Recall Z-0611-2007
Guidant Cardiac Surgery · initiated December 1, 2006
Product
Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.
Codes / lots: All products with expiry dates of June 2008, lot codes ranging from 4120181 to 6100281. See below. 5042281 5071983 5041981 5090881 5102481 5120581 6020881 6050281 6061581 6080581 6091281 4120181 5042581 5072181 5051881 5091281 5102482 5120681 6021081 6050381 6061981 6080781 6091381 4120381 5042981 5072281 5051981 5091381 5102581 5120781 6021381 6050681 6062081 6080881 6091382 4120681 5050281 5072681 5052181 5091481 5102681 5120881 6021581 6050881 6062181 6080882 6091481 4120781 5050381 5072781 5053181 5091981 5102682 5120981 6021681 6051081 6062281 6080981 6092081 4120881 5050481 5072782 5060281 5091982 5102781 5121481 6022281 6051181 6062381 6080982 6092181 4121081 5051081 5080381 5060381 5092081 5102881 5121981 6022781 6051281 6062382 6081081 6092681 4121381 5051181 5080382 5060681 5092082 5102882 5121982 6022782 6051381 6062681 6081082 6092781 4121481 5051281 5080481 5060781 5092181 5103181 5122081 6022881 6051681 6062781 6081281 6092881 4121881 5051381 5080482 5062181 5092182 5110781 6010381 6030181 6051682 6062881 6081481 6092981 4122081 5051681 5080581 5062281 5100181 5110881 6010382 6030381 6051981 6062981 6081482 6100281 4122181 5051781 5080881 5062282 5100381 5110981…
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.
FDA-determined 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.
Details
- Recall number
- Z-0611-2007
- Initiated
- December 1, 2006
- Posted by FDA
- March 16, 2007
- Terminated
- December 4, 2007
- Product code
- MWS – Stabilizer, Heart
- Quantity
- 57,691 units distributed total
- Distribution
- Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.
- Recalling firm
- Guidant Cardiac Surgery, Santa Clara, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0612-2007 | Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in… | 12/01/2006Terminated |