Drug recall

Blood and Blood Products for Reprocessing

FDA recall event 79844 · Class II, Class III · HCSC Blood Center dba as Miller-Keystone Blood Center

Key facts

Event ID 79844
Recall numbers B-0552-2018, B-0553-2018
Recalling firm HCSC Blood Center dba as Miller-Keystone Blood Center
Product type Biologics
Products Blood and Blood Products for Reprocessing, Red Blood Cells, Leukocytes Reduced
Classification Class II, Class III
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Initiation date Jan 12, 2018
Report date May 23, 2018
Termination date May 16, 2018
City Bethlehem
State PA
Country United States
FEI number 2573135

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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