Recall Z-1395-05 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085
| Date | Aug 24, 2005 (initiated Jun 14, 2005) |
| Status | Terminated |
| Reason | Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value calculations. |
| Root cause | Other |
| Action | Baxter sent Important Product Information letters dated 6/14/05 to all System 1000 and Arena Hemodialysis customers, to the attention of the Hemodialysis Administrator, via first class mail. Enclosed with the letter were copies of addenda to the Operator''s Manual for both the System 1000 and Arena instruments. The letter informed the accounts of the following problems: a) Improper Syringe Size - it is important to use the correct syringe size for heparin infusion to avoid improper infusion of heparin. The warning 'Ensure the instrument is properly configured for the type and size of hepari |
| Quantity | 623 units |
| Distribution | Nationwide and internationally to Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, India, Indonesia, Korea, Mexico, Peru, Philippines, Singapore, Spain, Switzerland, Taiwan, Thailand and Turkey. |
| 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 |