Recall Z-2049-2016 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Baxter Healthcare Corp.
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
| Date | Jun 24, 2016 (initiated May 23, 2016) |
| Status | Terminated |
| Reason | Presence of leaks near top of the PrismaSate bags |
| Root cause | Other |
| Action | Baxter Healthcare Corporation sent an Urgent Product Recall communication to affected customers via U.S.P.S. first class mail on 05/23/2016. |
| Quantity | 10,054 units |
| Distribution | Distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY Gambro Renal Products, Feb 4, 2008 |