Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying 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 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 26,422 units of Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. The affected lots are SSF02 and SSF03. This medical device is 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 product. The agency classification for this recall is Class II.
The product was distributed worldwide, including the United States (nationwide), Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore. Users should stop using the affected lots and contact Superstat Corporation for further instructions.
The recalled product
- Product
- Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. 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 capi
- 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# SSF02
- SSF03.
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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