GELITA MEDICAL GMBH recalls ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
- Recall date
- July 27, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1768-2022
- FDA classification
- Class II
- Brand / firm
- GELITA MEDICAL GMBH
- Sold / distributed
- US Nationwide distribution in the state of Alabama.
Why it was recalled
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
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