Orca Foam Standard Cube 10x10x10 Mm recall: Endotoxin
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Why was Orca Foam Standard Cube 10x10x10 Mm recalled?
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
- Recalling firm
- GELITA MEDICAL GMBH
- Quantity
- 3596 boxes of 50 devices
- Distribution
- US Nationwide distribution in the state of Alabama.
- Recall date
- September 28, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)