Retiro De Equipo (Recall) de Device Recall UltraFiltration (UF) Removal Regulators

Recall

35706

Class 3

Z-1253-06

2006-06-21

2006-07-25

Terminated

United States

2008-03-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46645

The uf removal regulators were assembled incorrectly. the mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.

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.