Enforcement Report - Week of July 18, 2012
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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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Platelets | 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 | Class III | Blood products, manufactured from Whole Blood units which may have reached an unacceptable temperature during shipment, were distributed. | 147 units | B-1656-12 |
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