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U.S. Department of Health and Human Services

Safety

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PLAS+SD (Pooled Plasma, (Human) Solvent Detergent Treated)

Audience: Transplantation Health Care Professionals

Healthcare professionals were advised of the addition of a Boxed Warning and a strengthened Warning section in the labeling for PLAS+SD (Pooled Plasma,(Human) Solvent Detergent Treated). The new Boxed Warning contraindicates the use of PLAS+SD in patients undergoing liver transplant, patients with severe liver disease and known coagulopathies. In addition, the Warnings have been strengthened to advise that patients receiving large volumes of PLAS+SD be monitored for evidence of thrombosis, excessive bleeding, or exacerbation of DIC. PLAS+SD is manufactured by V.I. Technologies, Inc. and distributed by American National Red Cross, Blood Services.

[March 29, 2002 - Dear Health Care Provider Letter - V.I. Technologies]

Past MedWatch Alerts
[October 20, 2000 - Letter - V. I. Technologies, Inc.]