Device product

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

Z-1768-2022

July 27, 2022

Class II

Product summary

Firm: GELITA MEDICAL GMBH
Event: Event 90743
Status: Completed
Classification: Class II
Quantity: 3596 boxes of 50 devices
Official record key: device-enforcement:Z-1768-2022

Official wording

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

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

Distribution pattern: US Nationwide distribution in the state of Alabama.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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