Recall Z-0377-2019 ยท KGN Wound Dressing With Animal-Derived Material(S)
AROA BIOSURGERY
Endoform Dermal Template 2x2, SKU 529311 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.
| Date | Nov 2, 2018 (initiated Nov 27, 2018) |
| Status | Terminated |
| Reason | Potential for pouch seal failure |
| Root cause | Employee error |
| Action | The firm sent a Customer Notification letter dated November 27, 2018. The letter identified the affected product, problem and actions to be taken. Customers are encouraged to visually inspect the seals on devices from these lots prior to use with particlar care. Should you observe a comprimised seal, please discard the device and select a new, fully sealed device for use. |
| Quantity | 8,853 total boxes |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092096 | ENDOFORM DERMAL TEMPLATE Mesynthes, Ltd., Jan 21, 2010 |