Recall Z-0294-2016 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
| Date | Oct 23, 2015 |
| Status | Terminated |
| Reason | Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. |
| Root cause | Device Design |
| Action | Fresenius issued an Urgent - Medical Device Correction notification, dated October 21, 2015, on 10/27/15. The letter identified the affected device and the reason for the recall. It also contained instructions (on how to perform the required wiring modification) along with a Reply Form. Customers are to return the form after completing the modification. Inquiries regarding the correction should be directed to Fresenius Technical Services at 800-227-2572, referencing the Field Action number FA-2015-01-W. |
| Quantity | 918 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING Fresenius USA, Inc., Jul 17, 1991 |