AROA BIOSURGERY recalls Endoform Dermal Template 2x2 (SKU 529311) due to potential pouch seal failure. Affected lots EDT-7H06, EDT-7L01, EDT-7L03, EDT- 8A01. Contact for return instructions.
Potential for pouch seal failure
AROA BIOSURGERY is recalling Endoform Dermal Template 2x2 (SKU 529311) because the pouch seal might fail, which could lead to the product not staying sterile during use. This is a serious risk for medical procedures where sterility is critical.
The pouch seal might fail during use, causing the template to lose sterility. This could lead to infection or complications in wound healing if the product is not properly sterile.
Patients using this specific surgical template for wound care are affected. Healthcare providers who use the product for medical procedures are at highest risk.
Check for the SKU 529311 on the product label. Affected lots include EDT-7H06, EDT-7L01, EDT-7L03, and EDT-8A01. The product is a sterile, single-use surgical template.
Immediately stop using the Endoform Dermal Template 2x2 if you have it.
No, the product has a potential for pouch seal failure, which could compromise sterility during use.
The official recall does not specify a return process or alternative solutions.
Affected lots are EDT-7H06, EDT-7L01, EDT-7L03, and EDT-8A01.
We’ve drafted a message you can send AROA BIOSURGERY to request your refund or repair — edit it as you like.
Subject: Recall Z-0377-2019 — AROA BIOSURGERY AROA BIOSURGERY Hello, I own a AROA BIOSURGERY that is covered by recall Z-0377-2019 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.
