FDA recall Z-1768-2022

GELITA MEDICAL GMBH · Class II · device

Product

ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

Reason for recall

In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

Distribution

US Nationwide distribution in the state of Alabama.

Key facts

Status
Completed
Initiation date
2022-07-27
Report date
2022-09-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eberbach, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2022