AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 4x5 due to a potential for pouch seal failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where a seal failure could compromise sterility, representing a risk of harm where injury has not yet been reported.
Plain-English summary
AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 4x5 (SKU 529313) because of a potential for pouch seal failure. The product is a sterile, single-use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
The recall affects lot numbers EDT-7I02 and EDT-7L02, which were distributed nationwide in the United States. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare providers and patients should stop using the affected product and contact AROA Biosurgery for further instructions or a replacement.
The recalled product
- Product
- Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
- Manufacturer
- AROA BIOSURGERY
- Category
- Medical Device — Wound Care
- Affected units
- 8,853
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers: EDT-7I02 EDT-7L02
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by AROA BIOSURGERY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · AROA BIOSURGERY
See all →- HighAROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
FDA (Devices) · 2018-11-14
- ModerateAROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
FDA (Devices) · 2018-11-14
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