Reported Sep 28, 2022 · Completed
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Gelita Medical GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GELITA MEDICAL GMBH · Uferstr. 7 · Eberbach, N/A · N/A
Is this the product you have?
- ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
- Lot codes and dates
4 of 4 products · 8 lot codes
Recalled lot codes, grouped by product number Batch Numbers Lot codes and dates T023711expiration date 10.02.2026
T023712expiration date 10.02.2026
T023951expiration date 07.05.2026
T023942expiration date 07.05.2026
- Amount recalled
- 3596 boxes of 50 devices
Where it was sold
- Nationwide
- AL
Why it was recalled
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
This product could cause temporary or reversible health problems — stop using it.
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