Recall Z-0085-2023 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Prismaflex HF20 Set (product code 109841). 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 | 29,764 devices |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042938 | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS Gambro Renal Products, Jan 6, 2005 |