FDA Recall
Completed
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Recall: Z-1768-2022
·
Initiated July 27, 2022
Recall
- Recall Number
- Z-1768-2022
- Event Number
- 90743
- Firm
- GELITA MEDICAL GMBH Uferstr. 7 Eberbach Germany
- FEI Number
- 3010208179
- Product Code
- LYA
- Status
- Completed
- Root Cause
- Under Investigation by firm
- Initiated
- July 27, 2022
Description
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Reason
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Action
The firm emailed a Field Safety Notice to the sole consignee, a distributor, on 07/27/2022, 08/11/2022 and 08/15/2022. The first letter explained the problem, hazard, and requested the return of the product. If the product was further distributed to notify customers. The second and third letters requested that the recalled articles be destroyed.
Distribution
US Nationwide distribution in the state of Alabama.
Quantity
3596 boxes of 50 devices