Recall Z-1449-2022 ยท PUI Drape, Surgical, Exempt
Aesculap Implant Systems LLC
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
| Date | Oct 1, 2019 |
| Status | Terminated |
| Reason | Packaging seal integrity not validated resulting in a lack of sterility assurance. |
| Root cause | Package design/selection |
| Action | Recall notice issued October 1, 2019 via letter mailed USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or email: emailorders@aesculapusa.com |
| Quantity | 4500 pieces |
| Distribution | United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.