Home / Recalls / Medical Devices
GELITA MEDICAL GMBH recalls ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Recalled September 28, 2022 · FDA recall Z-1768-2022 · GELITA MEDICAL
Hazard
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. · FDA Class II
Units
3596 boxes of 50 devices
Sold at
US Nationwide distribution in the state of Alabama.
Description
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Product
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Manufacturer(s)
GELITA MEDICAL GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →