Recall Z-0247-2020 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
TherMax Blood Warmer Unit
| Date | Oct 30, 2019 (initiated Sep 19, 2019) |
| Status | Terminated |
| Reason | TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds. |
| Root cause | Device Design |
| Action | Baxter Healthcare notified customers on about 09/19/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that specific TherMax Blood Warmers listed below may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds. The affected units may not have an adequate ground path, which could cause the units to become damaged if used with improperly grounded outlets. The damage could cause the TherMax Blood Warmer units to be nonfunctional during clinical use. Instructions inclu |
| Quantity | 504 units total |
| Distribution | Nationwide distribution to Georgia and Maryland. International distribution to Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Australia, and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190910 | PrisMax System Version 2 Baxter Healthcare Corp, Jul 25, 2019 |