Drug recall

Red Blood Cells, Leukocytes Reduced

FDA recall event 92318 · Class II · Versiti Indiana Inc

Key facts

Event ID 92318
Recall numbers B-0455-2023
Recalling firm Versiti Indiana Inc
Product type Biologics
Products Red Blood Cells, Leukocytes Reduced
Classification Class II
Status Terminated
Voluntary or mandated Voluntary: Firm Initiated
Reason for recall Leukoreduced Red Blood Cells, which were incorrectly labeled as irradiated, were distributed.
Initiation date Mar 2, 2023
Report date Jun 7, 2023
Termination date May 26, 2023
City Indianapolis
State IN
Country United States
FEI number 1873403

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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