Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGa
FDA device recall Z-0173-2012 · posted 2011-11-07 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 1 unit
- Distribution
- Distributed in Puerto Rico only.
- Date initiated
- 2011-09-19
- Date posted
- 2011-11-07
- Date terminated
- 2011-11-07
- Location
- Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM (K970446) | Althin Medical AB an Affiliate of Baxter Intl | 1997-06-02 |