Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge 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. Per the rubric, this falls under 'Minor labeling errors, low-risk contamination, voluntary precautionary recalls' as no specific injuries or illnesses are reported in the source text.
Plain-English summary
Superstat Corporation is recalling 26,422 units of Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. The affected lots are SSC02 and SSF02. This medical device is 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 the United States (nationwide), 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 units and contact Superstat Corporation for further instructions.
The recalled product
- Product
- Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. 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…
- 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# SSC02
- SSF02 .
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
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
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