Drug recall

Blood and Blood Products for Reprocessing

FDA recall event 85548 · Class II · Gulf Coast Regional Blood Center

Key facts

Event ID 85548
Recall numbers B-0471-2020, B-0472-2020
Recalling firm Gulf Coast Regional Blood Center
Product type Biologics
Products Blood and Blood Products for Reprocessing, Red Blood Cells, Leukocytes Reduced
Classification Class II
Status Terminated
Voluntary or mandated Voluntary: Firm Initiated
Reason for recall Blood products, collected from a donor who was previously deferred for high risk behavior, were distributed.
Initiation date Feb 19, 2020
Report date May 13, 2020
Termination date May 5, 2020
City Houston
State TX
Country United States
FEI number 3002133806

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 · Source date:

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