Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques |
|---|---|
| Recall Number | Z-0343-2013 |
| Classification | Class II |
| Code Info | Lot# SSN12D. |
| Product Distributed Qty | 26,422 units total |
| Reason For Recall | The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge. |
Event Detail
| Event Id | 63581 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Superstat Corp |
| City | Rancho Dominguez |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-24 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore. |
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