Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0342-2013 — Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. 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 alm

U.S. FDA — Device Enforcement · United States · 2012-10-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0342-2013
Date of alert: 2012-10-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Superstat Corp
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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