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). |
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| 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. |
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