Enforcement Report - Week of February 27, 2013
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Product Detail
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Recall Number | B-0403-13 |
| Classification | Class III |
| Code Info | 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 |
| Product Distributed Qty | 106 units |
| Reason For Recall | Blood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed. |
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 |
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