PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
FDA device recall Z-2049-2016 · posted 2016-06-24 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Presence of leaks near top of the PrismaSate bags
- Action taken
- Baxter Healthcare Corporation sent an Urgent Product Recall communication to affected customers via U.S.P.S. first class mail on 05/23/2016.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 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
- Date initiated
- 2016-05-23
- Date posted
- 2016-06-24
- Date terminated
- 2017-03-28
- Location
- Deerfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY (K072908) | Gambro Renal Products | 2008-02-04 |