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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description 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).
Recall Number B-2152-12
Classification Class II
Code Info 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
Product Distributed Qty 26 Donors
Reason For Recall Human semen, collected from donors that did not have repeat physical exam within 6 months prior to donation, was distributed.

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.