Recall Z-0378-2019
Aroa Biosurgery · initiated November 27, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Endoform Dermal Template 2x2, SKU 529312 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.
Codes / lots: Lot numbers: EDT-7I01 EDT-7K01 EDT-7L05
Reason for recall
Potential for pouch seal failure
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0378-2019
- Initiated
- November 27, 2018
- Posted by FDA
- November 2, 2018
- Terminated
- April 9, 2019
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Quantity
- 8,853 total boxes
- Distribution
- US Nationwide Distribution
- Recalling firm
- Aroa Biosurgery, Airport Oaks
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0377-2019 Class II | Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a…Potential for pouch seal failure | 11/27/2018Terminated |
| Z-0379-2019 Class II | Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a…Potential for pouch seal failure | 11/27/2018Terminated |