Z-0173-2012

Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal...

Name: Z-0173-2012 Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal...
Creator: Baxter Healthcare Renal Div
Published: 2011-09-19
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2011-09-19 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Renal Div began a recall of Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code... on 2011-09-19. The reason FDA records is "The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0173-2012
Status: Terminated
Initiated: 2011-09-19
Posted: 2011-11-07
Terminated: 2011-11-07
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
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 unit
Distribution: Distributed in Puerto Rico only.
Product codes and lots: product code S1000L3P, Serial Number 28130

Product code KDI

K970446Class IIDrake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl / cleared 1997-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)