FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis
- Recall number
- Z-0173-2012
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis
- Status
- Terminated
- Initiated
- 2011-09-19
- Posted
- 2011-11-07
- Terminated
- 2011-11-07
- Reason
- The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
- Root cause
- Employee error
- Action
- Baxter Healthcare Corporation sent a service technician to the lone customer site on September 19, 2011 to correct the affected product. The technician executed all tests as established in the Service Manual, with acceptable results.
- Quantity
- 1 unit
- Distribution
- Distributed in Puerto Rico only.
- Lot, serial or model codes
- product code S1000L3P, Serial Number 28130
- 510(k) numbers
- ["K970446"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3000210122
- Firm city
- Park
- 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