Recall Z-1253-06 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis Instruments; Baxter Healthcare Corporation, Deerfield, IL 60015; item numbers 6001276024 and 6001276028
| Date | Jul 25, 2006 (initiated Jun 21, 2006) |
| Status | Terminated |
| Reason | The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 06/21/06 to all System 1000, TINA, Altratouch, Arena and Aurora Hemodialysis Instrument customers who may have received the nonconforming assemblies via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the three lots of UF Removal Regulators were potentially assembled incorrectly. While these regulators are identical in appearance to properly assembled components, the mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy |
| Quantity | 569 units |
| Distribution | Worldwide Distribution including the states of Arizona, California, Connecticut, Florida, Georgia, Maryland, Missouri, Ohio, Oklahoma, Tennessee, Texas and Puerto Rico, and international distribution to Belgium, Canada, Thailand, Chile, Austrailia, Peru, Argentina, Panama and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030099 | BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 Baxter Healthcare Corp, Jun 17, 2003 |
| K103562 | CENTURION PRESSURE INJECTABLE EXTENSION SET Centurion Medical Products Corporation, Jun 23, 2011 |
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST Cd Medical, Inc., Apr 9, 1991 |
| K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl, Jun 2, 1997 |