Aspen Surgical Products, Inc. Recall: Norton Arm Kit, Product Code 711400, (previous produ
Aspen Surgical Products, Inc. Recall: Norton Arm Kit, Product Code 711400, (previous produ is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Aspen Surgical Products, Inc.; Product: Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400; Reason for recall:
| Recalling firm | Aspen Surgical Products, Inc. |
|---|---|
| Product | Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400 |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US nationwide distribution. No foreign distribution. |
| Recall initiated | 20210723 |
| Recall number | Z-2390-2021 |
| Category | device |
| State | MI |
| Country | United States |
$29/mo
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