Drug recall

Fresh Frozen Plasma

FDA recall event 27812 · Class II · American National Red Cross Great Lakes Region

Key facts

Event ID 27812
Recall numbers B-0433-4, B-0434-4
Recalling firm American National Red Cross Great Lakes Region
Product type Biologics
Products Fresh Frozen Plasma, Red Blood Cells, Leukocytes Reduced
Classification Class II
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob Disease (nvCJD), was distributed.
Initiation date Oct 3, 2003
Termination date Jan 23, 2004
City Lansing
Country United States
FEI number 1873033

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports

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