Recall Z-0518-2019 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
| Date | Oct 9, 2018 |
| Status | Terminated |
| Reason | Discolored powder has confirmed the presence of a foreign substance |
| Root cause | Under Investigation by firm |
| Action | Fresenius issued on 10/9/18 via Certified Mail An Urgent Medical Device Recall Customer Notification to affected consignees asking the consignees to check their stock immediately. If they have any listed GranuFlo Dry Acid Concentrate lot. numbers discontinue use immediately and place the product in a secure, segregated area. The Urgent Medical Device Recall Customer Notification ask for the return of the affected lots and to contact Stericycle on instructions how to return the recalled lots. Contact Stericycle at 1-888-671-8851 for instructions on how to return the recalled product. This is E |
| Quantity | 22320 |
| Distribution | Distribution US nationwide and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES Fresenius Medical Care, May 20, 2003 |