FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Prismaflex System, Prismaflex Control Unit
- Recall number
- Z-1832-2020
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Prismaflex System, Prismaflex Control Unit
- Status
- Terminated
- Initiated
- 2020-02-06
- Posted
- not on file
- Terminated
- 2021-06-01
- Reason
- Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- Root cause
- Under Investigation by firm
- Action
- Baxter is asking customers to: 1. Operators may continue to safely use the Prismaflex control unit according to the warnings and cautions in the Prismaflex Operators Manual. 2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email.
- Quantity
- 626
- Distribution
- Distribution in US, Puerto Rico
- Lot, serial or model codes
- Product Code:955542; GTIN 07332414124236
- 510(k) numbers
- ["K072093","K110823"]
- PMA numbers
- not on file
- Product code
- KDI
- 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