FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
- Recall number
- Z-2049-2016
- Recalling firm
- Baxter Healthcare Corp.
- Product
- PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
- Status
- Terminated
- Initiated
- 2016-05-23
- Posted
- 2016-06-24
- Terminated
- 2017-03-28
- 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
- Lot, serial or model codes
- Listing #D051124, Unique Device Identifier #07332414037048, Product code #105351. Lot code (Exp date): 1000123133 (02/28/2017), 1000128162 (04/30/2017), 1000128163 (04/30/2017), 1000128164 (04/30/2017).
- 510(k) numbers
- ["K072908"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28