Reported Nov 28, 2012 · Terminated
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is…
Superstat Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Superstat Corp · 2015 E University Dr · Rancho Dominguez, CA · 90220-6411
Is this the product you have?
- 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, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
- Lot codes and dates
Lot#P0616PSSK15P
- Amount recalled
- 26,422 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Superstat Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.