Recall Z-0681-06 ยท KOC Accessories, Blood Circuit, Hemodialysis
Baxter Healthcare Renal Div
Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R
| Date | Mar 29, 2006 (initiated Dec 21, 2005) |
| Status | Terminated |
| Reason | Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system. |
| Root cause | Other |
| Action | Important Product Information letters dated 12/21/05 were sent to all BM-series instrument users, informing them of the potential for kinking of the tubing if the hemofilter is in the vertical position and the compatibility testing conducted on certain blood tubing sets for use with the BM-series instruments and Baxter''s recommendation that the following sets be used with the BM-series instruments: a) product code 5M3006M for use with the BM 11 and the BM 11a, when the BM 11a is used as a stand alone device; b) product code 5M3048 for use with the BM 11a when operated as part of the BM 25 Sys |
| Quantity | 532 units |
| Distribution | Nationwide including Puerto Rico, and internationally to Colombia, Hong Kong and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911315 | EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT Baxter Healthcare Corp, Oct 30, 1991 |