Recall Z-0173-2012 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis
| Date | Nov 7, 2011 (initiated Sep 19, 2011) |
| Status | Terminated |
| Reason | The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test. |
| Root cause | Employee error |
| Action | Baxter Healthcare Corporation sent a service technician to the lone customer site on September 19, 2011 to correct the affected product. The technician executed all tests as established in the Service Manual, with acceptable results. |
| Quantity | 1 unit |
| Distribution | Distributed in Puerto Rico only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl, Jun 2, 1997 |