Drug recall

AS-1 Red Blood Cells Leukocytes Reduced Irradiated

FDA recall event 45289 · Class II · American National Red Cross, Penn Jersey Region

Key facts

Event ID 45289
Recall numbers B-1004-08, B-1005-08, B-1006-08, B-1007-08, B-1008-08, B-1009-08, B-1010-08, B-1011-08, B-1012-08, B-1013-08, B-1014-08
Recalling firm American National Red Cross, Penn Jersey Region
Product type Biologics
Products AS-1 Red Blood Cells Leukocytes Reduced Irradiated, Cryoprecipitated AHF, Fresh Frozen Plasma, Plasma Cryoprecipitate Reduced, Plasma Frozen within 24 hours after phlebotomy and 6 more
Classification Class II
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed., Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Initiation date Jul 16, 2007
Termination date Mar 27, 2008
City Philadelphia
State PA
Country United States
FEI number 2573021

At a glance

  • 10–99 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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