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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 61564
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Farmington
State CT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-16
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern CT, NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced 033KX34123, 033KX34094, 033KX34095, 033KX34096, 033KX34097, 033KX34098, 033KX34099, 033KX34101, 033KX34102, 033KX34103, 033KX34104, 033KX34105, 033KX34106, 033KX34107, 033KX34124, 033KX34125, 033KX34126, 033KX34127, 033FN44900, 033FN44901, 033FN44890, 033FN44891, 033FN44893, 033FN44894, 033FN44895, 033FN44897, 033FN44898, 033FN44899, 033FN44879, 033FN44880, 033FN44881, 033FN44882, 033FN44883, 033FN44884, 033FN44885, 033FN44886, 033FN44887, 033FN44888, 033FN44889, 033KX34131, 033KX34132, 033KX34133, 033KX34134, 033KX34136, 033KX34138, 033KX34139, 033KX34140, 033KX34141, 033KX34129, 033KX34130, 033FN44851, 033FN44852, 033FN44853, 033FN44854, 033FN44855, 033FN44856, 033FN44857, 033FN44858, 033FN44859, 033FN44860, 033FN44862, 033FN44863, 033FN44864, 033FN44866, 033FN44868, 033FN44869, 033FN44870, 033FN44871, 033FN44873, 033FN44874, 033FN44875, 033FN44876, 033FN44878, 033KX34142, 033KX34143, 033KX34144, 033KX34145, 033KX34146, 033FN44847, 033FN44849, 033FN44850, 033KX34108, 033KX34109, 033KX34110, 033KX34111, 033KX34112, 033KX34113, 033KX34114, 033KX34115, 033KX34116, 033KX34117, 033KX34118, 033KX34119, 033KX34120, 033KX34121, 033KX34122, 033FN44903, 033FN44905, 033FN44906, 033FN44907, 033FN44908, 033FN44909, 033FN44910, 033FN44911, 033FN44912, 033FN44914 Class III Blood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed. 106 units B-0403-13
Red Blood Cells Leukocytes Reduced Irradiated 033KX34128, 033FN44892, 033FN44865, 033FN44846, 033FN44902, 033FN44913, 033FN44915 Class III Blood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed. 7 units B-0404-13
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