Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation to verify quarterly dose sterility audits is unavailable.
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 due to missing documentation for sterility audits, which is a documentation issue rather than a confirmed contamination or injury event, fitting the Moderate severity criteria for low-risk or precautionary recalls.
Plain-English summary
Superstat Corporation is recalling the Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. The recall affects 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 specific lots involved are R1018P, S1503P, S2802P, and SSN03P.
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. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the product. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding the disposal or return of the recalled sponges.
The recalled product
- Product
- Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. 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, eit
- 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 (4)
- Lot# R1018P
- S1503P
- S2802P
- SSN03P .
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
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See all →- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Gaps
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
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