Aspen Surgical Products, Inc. Recall 88476
Description: Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Aspen Surgical Products, Inc. Recall 88476 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2390-2021 |
| Event ID | 88476 |
| Event Description | Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400 |
| Product Type | Devices |
| Distribution | US nationwide distribution. No foreign distribution. |
| Quantity | 124 |
| Recall 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. |
| Device Classification | 20210908 |
| Device Code Info | All lots manufactured between July 9, 2019 to July 9, 2021 |
| Center Classification Date | 20210830 |
| Recall Initiation Date | 20210723 |
| Recalling Firm | Aspen Surgical Products, Inc. |
| Initial Notification | Letter |
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