Superstat Corp Recall: Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, P
Superstat Corp Recall: Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, P is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Superstat Corp; Product: Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along
| Recalling firm | Superstat Corp |
|---|---|
| Product | Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. 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 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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. |
| Recall initiated | 20121024 |
| Recall number | Z-0338-2013 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
Try RecallGuard →