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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 61075
Product Type Biologics
Status Ongoing
Recalling Firm Seattle Sperm Bank LLC
City Seattle
State WA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-10-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Approximately two thirds of product went to Denmark, Australia, Canada, and Mexico. The remaining one third distributed domestically nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Human semen for intracervical insemination and/or intrauterine insemination. Vials are labeled with the donor number, date of donation, and "Seattle Sperm Bank". Vials that are for intrauterine insemination (IUI-ready) have a green color band indicating it is ready for intra uterine insemination after thawing. Vials that do not have a green band indicate that the semen is an intra cervical insemination sample (ICI). Vials are labeled with the donor number. Affected donor numbers are: 8503, 8505, 8508, 8509, 8521, 8523, 8528, 8534, 8535, 8543, 8547, 8552, 8558, 8566, 8578, 8579, 8582, 8598, 8609, 8612, 8615, 8625, 8636, 8643, 8652, and 8664 Class II Human semen, collected from donors that did not have repeat physical exam within 6 months prior to donation, was distributed. 26 Donors B-2152-12
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