FDA Recall
Terminated
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.
Recall: Z-0378-2019
·
Initiated November 27, 2018
Recall
- Recall Number
- Z-0378-2019
- Event Number
- 81161
- Firm
- AROA BIOSURGERY 2 Kingsford Smith Place Airport Oaks New Zealand
- FEI Number
- 3007321028
- Product Code
- KGN
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- November 27, 2018
- Posted
- November 2, 2018
- Terminated
- April 9, 2019
Description
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.
Reason
Potential for pouch seal failure
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.
Distribution
US Nationwide Distribution
Quantity
8,853 total boxes