FDA Recall
Terminated
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: Z-0173-2012
·
Initiated September 19, 2011
Recall
- Recall Number
- Z-0173-2012
- Event Number
- 60183
- Firm
- Baxter Healthcare Renal Div
- FEI Number
- 3000210122
- Product Code
- KDI
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- September 19, 2011
- Posted
- November 7, 2011
- Terminated
- November 7, 2011
- Address
- 1620 Waukegan Rd, Mc Gaw Park, IL, 60085-6730
Description
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
Reason
The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
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.
Distribution
Distributed in Puerto Rico only.
Quantity
1 unit