Recall Z-1768-2022
Gelita Medical GmbH · initiated July 27, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Codes / lots: UDI/DI 00860003109915, Batch Numbers: T02371/1, expiration date 10.02.2026; T02371/2, expiration date 10.02.2026; T02395/1, expiration date 07.05.2026; T02394/2, expiration date 07.05.2026
Reason for recall
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1768-2022
- Initiated
- July 27, 2022
- Product code
- LYA – Splint, Intranasal Septal
- Quantity
- 3596 boxes of 50 devices
- Distribution
- US Nationwide distribution in the state of Alabama.
- Recalling firm
- Gelita Medical GmbH, Eberbach