Drug recall

Pooled Cryoprecipitated AHF

FDA recall event 95859 · Class II · OneBlood, Inc.

Key facts

Event ID 95859
Recall numbers B-0115-2025
Recalling firm OneBlood, Inc.
Product type Biologics
Products Pooled Cryoprecipitated AHF
Classification Class II
Status Terminated
Voluntary or mandated Voluntary: Firm Initiated
Reason for recall Pooled Cryoprecipitated AHF, labeled as having been pooled using a closed system, but was pooled in an open system, was distributed.
Initiation date Jun 25, 2024
Report date Apr 30, 2025
Termination date Apr 23, 2025
City Orlando
State FL
Country United States
FEI number 1072425

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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