Recall Z-1207-2009 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Biomet, Inc.
Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800-0613A. The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
| Date | Apr 17, 2009 (initiated Mar 5, 2009) |
| Status | Terminated |
| Reason | A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube. |
| Root cause | Process control |
| Action | Consignees were notified by "URGENT MEDICAL DEVICE REMOVAL NOTICE " dated March 5, 2009 and instructed to locate and return the recalled products. Direct questions about this recall to Biomet Orthopedics at 1-800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM. |
| Quantity | 27 total kits of both products |
| Distribution | Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071934 | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT Biomet Manufacturing Corp, Oct 11, 2007 |