Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly 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. Per the rubric, this falls under moderate severity as it is a voluntary precautionary recall without reported illnesses or injuries.
Plain-English summary
Superstat Corporation is recalling 26,422 units of Superstat Modified Collagen Hemostatic Sponge, 115mmx115mm Pledget, 1.5%, Part#9500-15. The affected lots are P0616P and SSK15P. These medical devices are indicated for use when hemostasis is desired along suture lines, in diffusely bleeding sites, and in incisions or wounds.
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 has classified this recall as Class II.
The product was 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 patients should stop using the affected lots and contact Superstat Corporation for further instructions.
The recalled product
- Product
- Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. 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, eithe
- 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#P0616P
- SSK15P
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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