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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 42697
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Center of the Ozarks
City Springfield
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2006-07-14
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern MO; AR; NJ

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced Washed 6476878 Class III Blood products, manufactured from Whole Blood units with extended collection times, were distributed. 1 Unit B-1692-13
Plasma Cryoprecipitate Reduced 6568175 Class III Blood products, manufactured from Whole Blood units with extended collection times, were distributed. 1 Unit B-1691-13
Fresh Frozen Plasma 6562334; 6705196; 4243318; 6482869; 6497071; 6614538; 6496289; 6488930; 6559270; 6467217; 6524060; 6566610; 6582088; 6663526; 6476275; 6617680; 6610450; 6589186; 6464517; 6487193; 6547651; 6592478; 6473459; 6481957; 6495497; 6504761; 6517604; 6554011; 6565663; 6555912; 6567735; 6585224; 6697679; 6692573; 6570898; 6691603; 6617693; 6583196; 6477701; 6471337; 6708255 Class III Blood products, manufactured from Whole Blood units with extended collection times, were distributed. 41 Units B-1690-13
Platelets 6567735; 6554449; 6566610; 6488930; 6583196; 6471337; 6473459; 6487193; 6484513; 6504761; 6521015; 6617680; 6653373; 6708255; 4243318; 6617693; 6627057; 6517604; 6519075; 6518981; 6515638; 6487190; 6497614; 6464517; 6562334; 6477701; 6514649; 6692573; 6592478; 6661580; 6563569; 6559270; 6521050; 6497071 Class III Blood products, manufactured from Whole Blood units with extended collection times, were distributed. 34 Units B-1689-13
Cryoprecipitated AHF 6541216;6568175; 6471644; 6500266; 4243041 Class III Blood products, manufactured from Whole Blood units with extended collection times, were distributed. 5 Units B-1688-13
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