AROA BIOSURGERY recalls Endoform Dermal Template 4x5 (SKU 52931: EDT-7I02, EDT-7L02) due to potential pouch seal failure. This sterile single-use wound dressing may not stay sealed properly, risking infection.
Potential for pouch seal failure
AROA BIOSURGERY is recalling Endoform Dermal Template 4x5 (SKU 529313) because the pouch seal might fail, increasing infection risk. This is a single-use wound dressing for medical procedures.
The pouch seal may not stay closed properly during use, allowing contaminants to enter the wound. This could lead to infection if the dressing is not properly sealed.
Patients using this sterile single-use wound dressing for medical procedures. Those with open wounds or surgical sites are most at risk.
Check for the product name 'Endoform Dermal Template 4x5' and SKU 529313. Lot numbers EDT-7I02 or EDT-7L02 indicate the recalled items.
Look for SKU 529313 and lot numbers EDT-7I02 or EDT-7L02 on the packaging.
The recall is for potential pouch seal failure, which could increase infection risk. If you have the recalled lot numbers, stop using it.
Check for SKU 529313 and lot numbers EDT-7I02 or EDT-7L02 on the packaging.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send AROA BIOSURGERY to request your refund or repair — edit it as you like.
Subject: Recall Z-0379-2019 — AROA BIOSURGERY AROA BIOSURGERY Hello, I own a AROA BIOSURGERY that is covered by recall Z-0379-2019 from AROA BIOSURGERY. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
