Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis Instruments; Baxter Healthcare Corporation, Deerfield, IL 60015; item numbers 6001276024 and 6001276028
This recall has been terminated (originally issued July 25, 2006).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- June 21, 2006
- Posted
- July 25, 2006
- Terminated
- March 4, 2008
- Recall Number
- Z-1253-06
- Quantity
- 569 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.
Distribution
Worldwide Distribution including the states of Arizona, California, Connecticut, Florida, Georgia, Maryland, Missouri, Ohio, Oklahoma, Tennessee, Texas and Puerto Rico, and international distribution to Belgium, Canada, Thailand, Chile, Austrailia, Peru, Argentina, Panama and Mexico.
Lot / Code Info
item number 6001276024, lot numbers 01095126 and 01092479; part number 6001276028, lot number 01095127
Root Cause
Other
Action Taken
Baxter sent Urgent Device Correction letters dated 06/21/06 to all System 1000, TINA, Altratouch, Arena and Aurora Hemodialysis Instrument customers who may have received the nonconforming assemblies via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the three lots of UF Removal Regulators were potentially assembled incorrectly. While these regulators are identical in appearance to properly assembled components, the mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy. Replacement regulators were included with the recall letter, and the accounts were requested to return the regulators from their previous shipment to Baxter using the enclosed mailing materials. The accounts were requested to complete the enclosed reply form indicating the number of units received and the number of units returned and acknowledging receipt of the letter and dissemination of the information to their staff and to other services of facilities, as applicable, and fax the sheet to 1-727-544-3025. Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 1.