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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description Platelets
Recall Number B-1656-12
Classification Class III
Code Info 1061908, 1061928, 1061102, 1061392, 1061617, 1061619, 1061944, 1062026, 1062058, 1062063, 1063102, 1063111, 1063181, 1063183, 1063185, 1063255, 1063257, 1063460, 1063461, 1061513, 1061616, 1061700, 1061701, 1061338, 1061339, 1061343, 1061346, 1061525, 1061530, 1061533, 1061534, 1061535, 1061536, 1061622, 1061623, 1061647, 1061706, 1061707, 1061708, 1061709, 1061710, 1061711, 1061750, 1061752, 1061754, 1061755, 1061756, 1061758, 1061760, 1061761, 1061762, 1061764, 1061765, 1061766, 1061768, 1061771, 1061578, 1061579, 1061580, 1061583, 1061584, 1061585, 1061588, 1061589, 1061590, 1061593, 1061595, 1061596, 1061597, 1061598, 1061716, 1061718, 1061719, 1061776, 1061777, 1061780, 1061781, 1061782, 1061786, 1061789, 1061800, 1061801, 1061802, 1061806, 1061809, 1061811, 1061813, 1061814, 1061815, 1061816, 1061820, 1061821, 1061943, 1061241, 1061248, 1061461, 1061462, 1061466, 1061547, 1061795, 1061798, 1061903, 1061906, 1061912, 1061927, 1061929, 1061934, 1061937, 1061939, 1061519, 1061727, 1061728, 1061729, 1061731, 1061732, 1061741, 1061894, 1061949, 1061975, 1061976, 1061977, 1061978, 1061979, 1061985, 1061987, 1061990, 1062032, 1062043, 1062048, 1062109, 1062229, 1062326, 1062682, 1062683, 1062685, 1062686, 1062687, 1062688, 1063025, 1063027, 1063032, 1063034, 1063035, 1063037, 1063104, 1063178, 1063180
Product Distributed Qty 147 units
Reason For Recall Blood products, manufactured from Whole Blood units which may have reached an unacceptable temperature during shipment, were distributed.

Event Detail

Event Id 48825
Product Type Biologics
Status Terminated
Recalling Firm Aultman Hospital Blood Bank
City Canton
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-05-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern OH
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