Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Gaps
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly dose sterility audits were performed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation issue regarding sterility audits rather than a confirmed contamination event or reported injury, aligning with the rubric for moderate severity.
Plain-English summary
Superstat Corporation is recalling the Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. The recall involves 26,422 units distributed worldwide, including the United States, Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Isle of Man, Nova Scotia, and Singapore. The affected lots are R1018D, SSM02D, and SSN12D.
The recall was initiated because Superstat Corporation confirmed that no documentation is available to verify that quarterly dose sterility audits were performed for the product. The agency classified this as a Class II recall.
The product is indicated for use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. It is indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques. Users should contact Superstat Corporation for further instructions regarding the affected units.
The recalled product
- Product
- 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 capilla
- Manufacturer
- Superstat Corp
- Affected units
- 26,422
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# R1018D
- SSM02D
- SSN12D .
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Superstat Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Superstat Corp
See all →- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Documentation
FDA (Devices) · 2012-11-28
Same hazard · sterility verification
See all →- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28