Recall Z-0766-06 ยท FKP System, Dialysate Delivery, Single Patient
Baxter Healthcare Renal Div
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
| Date | Apr 18, 2006 (initiated Feb 24, 2006) |
| Status | Terminated |
| Reason | The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 02/24/06 to all System 1000, TINA, Altratouch and Aurora Hemodialysis Instrument customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the potential for the older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators to become cracked due to mechanical and thermal stress. Color photographs of the old style and new style components were included in the letter. The accounts were informed that if the cracking o |
| Quantity | 14,917 units |
| Distribution | Nationwide including Puerto Rico, and internationally to Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Lebanon, Morocco, the Netherlands, Nigeria, Oman, Poland, Romania, Russia, Slovakia, South Africa, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST Cd Medical, Inc., Apr 9, 1991 |