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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Event Detail

Event ID 64176
Product Type Biologics
Status Terminated
Recalling Firm Our Lady Of The Lake Hospital Inc
City Baton Rouge
State LA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-21
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern 5 in Louisiana

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W165712027965K, W165712027847W, W1657120268020, W1657120275793, W1657120243743, W165712024360F, W165712024396S, W165712024368, W1657120243663, W1657120243655, W1657120243647, W1657120243639, W165712027902D, W165712026691J, W1657120266228, W165712026191M, W1657120266164, W165712024260N, W1657120284020, W165712026586L Class II Blood products, collected from a potentially ineligible donor, were distributed. 20 units B-1584-13
Fresh Frozen Plasma W1657120266156, W165712026601I, W165712026599B, W165712024396S, W165712024395U, W165712024393Y, W1657120243903, W165712024368*, W1657120243671, W1657120243655, W1657120243647, W1657120250687, W165712024819E, W165712023827U, W165712027716H, W165712027712P, W165712027704P, W165712027700X, W1657120214666, W1657120213053, W165712021364I, W165712020867P, W165712019069A, W165712000939F, W165712019313Y, W165712018284C, W1657120182151, W165712018196C, W165712018100N, W165712018099E, W165712018097I, W1657120101824, W165712015088V, W165712016583M, W1657120149183, W165712007005W, W165712006336A, W165712006225O, W165712013834R, W165712013658R, W165712010491F, W165712010967C, W165712010925W, W165711028973L, W165712010427V, W1657120104240, W165712008629Q, W165712007439H, W165712006880*, W165712005346I, W165712005429G, W165712004663C, W1657120046101, W165712004483K, W165712004307F, W1657120023997, W1657120023989, W165712002389B, W165712002383N, W165712002376L, W165712000189M, W1657120213205, W1657120195793, W165712022369T, W1657120189617, W165712025372S, W165712000927N, W1657120009008, W165712018308S, W1657120182868, W165712018171U, W165712018106B, W1657120106401, W165712010637B, W165712010563F, W1657120099697, W1657120099140, W165712009810G, W165712018318Q, W165712016555U, W165712007447H, W165712007446J, W165712007008Q, W165712007007S, W165712006981Q, W165712006963U, W1657120132181, W165712011854E, W165712006093G, W165712010960Q, W165712009948H, W1657120102616, W165712009811E, W1657120098340, W1657120100960, W1657120100864, W165712010243A, W165712010177Z, W1657120101664, W165712008483U, W165712008705Y, W165712007432V, W165712007391H, W1657120061938, W165712002380T, W165712013501W, W165712024191H, W1657120146114, W165712016584K, W165712018007H, W1657120182876, W165712016589A Class II Blood products, collected from a potentially ineligible donor, were distributed. 112 units B-1583-13
Red Blood Cells (Apheresis) Leukocytes Reduced W1657120277545 (Part 1), W1657120277545 (Part 2), W165712023964C Bag 1, W165712023964C Bag 2 Class II Blood products, collected from a potentially ineligible donor, were distributed. 4 units B-1582-13
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