FDA-Device2022-09-28Class II
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
GELITA MEDICAL GMBH
Hazard
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Sold states
US Nationwide distribution in the state of Alabama.
Affected count
3596 boxes of 50 devices
Manufactured in
Uferstr. 7, N/A, Eberbach, N/A, Germany
Products
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2022Don't want to check this manually?
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