Recall Z-0081-2023 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
| Date | Oct 12, 2022 (initiated Sep 14, 2022) |
| Status | Open, Classified |
| Reason | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions. |
| Root cause | Error in labeling |
| Action | Baxter sent an Urgent Medical Device Correction notice to its direct consignees by USPS on 09/14/2022. The notice explained the Estonian translation issue and requested that the following actions be taken by consumers: 1. Use of the Prismaflex HF20 set should be restricted to patients with a body weight greater than 8kg (18lb). Use of the Prismaflex M60 and ST60 sets should be restricted to patients with a body weight greater than 11kg (24lb). Use of the Prismaflex M100, ST100, M150, ST150, HF1000 and HF1400 sets should be restricted to patients with a body weight greater than 30kg (66lb). 2. |
| Quantity | 524,376 devices |
| Distribution | US Nationwide |
| 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 |