Recall Z-1934-2009 ยท KRA Catheter, Continuous Flush
Edwards Lifesciences AG
Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)
| Date | Aug 25, 2009 (initiated Mar 14, 2008) |
| Status | Terminated |
| Reason | Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected. |
| Root cause | Equipment maintenance |
| Action | Edwards initiated the recall in the U.S. via a Urgent Customer lNotification letter with attached response confirmation fax-back attachment dated March 10, 2008 and was sent by Federal Express on March 12, 2008 requesting that customers cease using all "VAMP Jr" products and that they return all unused product. Customers were instructed to fax-back the confirmation attachment to 800-422-9329 and contact Edwards Customer service at 888-570-4012 to arrange for return of any unused product and obtain information about replacement product. Edwards Lifesciences requested that the customer provide |
| Quantity | 61,199 units |
| Distribution | Worldwide Distribution including USA and the countries of Australia, Austria, Belgium, Brazil, Canada, Canaric Island (Spain), China, Columbia, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Puerto Rico, Spain, Sweden, Turkey, and United K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K885281 | VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION Baxter Healthcare Corp, Mar 3, 1989 |