GELITA MEDICAL GMBH recalls ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Read the official notice →- Date
- 2022-09-28
- Country
- United States
- Brand
- GELITA MEDICAL GMBH
- Product
- ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
- Classification
- Class II
- Units
- US Nationwide distribution in the state of Alabama.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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