Reported Nov 14, 2018 · Terminated
Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine…
Aroa Biosurgery
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: AROA BIOSURGERY · 2 Kingsford Smith Place · Airport Oaks · N/A
Is this the product you have?
- Endoform Dermal Template 4x5
- SKU 529313 Product UsageEndoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment
- Lot codes and dates
- Lot numbersEDT-7I02 EDT-7L02
- Amount recalled
- 8,853 total boxes
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential for pouch seal failure
This product could cause temporary or reversible health problems — stop using it.
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