Z-1768-2022 Class II Terminated
FDA device recall Z-1768-2022 was initiated by GELITA MEDICAL GMBH on July 27, 2022 and is designated Class II. Reason for recall: In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. The recall status is terminated (terminated September 22, 2026). Affected quantity: 3596 boxes of 50 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2022
- Initiation Date
- July 27, 2022
- Termination Date
- September 22, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3596 boxes of 50 devices
Product Description
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 Pattern
US Nationwide distribution in the state of Alabama.
Code Information
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