Recall Z-2378-2021 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
| Date | Jul 22, 2021 |
| Status | Terminated |
| Reason | Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming |
| Root cause | Vendor change control |
| Action | The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees. |
| Quantity | 64275 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS Gambro Renal Products, Oct 7, 2004 |