Recall Z-2390-2021 ยท CCX Support, Patient Position
Aspen Surgical Products, Inc.
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
| Date | Jul 23, 2021 |
| Status | Terminated |
| Reason | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection. |
| Root cause | Process control |
| Action | Required Actions: 1. Check all storage and usage locations to confirm if you have any units of the affected item codes in your possession. Please note that these products bear an expiration date; any expired product should be discarded regardless of whether they are affected by this corrective action. 2. Distributors: Please check your inventory for affected products as indicated above. For products that you have distributed, please forward this notification to your customers who have received affected product. Please also provide to Aspen a list of customers who have received these produc |
| Quantity | 124 |
| Distribution | US nationwide distribution. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.