Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Superstat Corporation is recalling Superstat Modified Collagen Hemostatic Sponges, 32mm Disc, 1.5%, Part# 9120-15 and 9100-15. The recall involves 26,422 units from Lot# SSK02D and SSK05D. These medical devices are indicated for use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses.
The recall was initiated because Superstat Corporation confirmed that no documentation is available to verify that quarterly dose sterility audits were performed for the affected sponges. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the USA and in Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore. Healthcare providers and facilities should stop using the affected lots and contact Superstat Corporation for further instructions.
The recalled product
- Product
- Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. 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…
- 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 (2)
- Lot# SSK02D
- SSK05D.
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 Sterility Audit Documentation Gaps
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- 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
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