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
This recall has been terminated (originally issued November 7, 2011).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- September 19, 2011
- Posted
- November 7, 2011
- Terminated
- November 7, 2011
- Recall Number
- Z-0173-2012
- Quantity
- 1 unit
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
Distribution
Distributed in Puerto Rico only.
Lot / Code Info
product code S1000L3P, Serial Number 28130
Root Cause
Employee error
Action Taken
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.
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