Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Reported: September 8, 2021 Initiated: July 23, 2021 #Z-2390-2021
Product Description
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.
Details
- Recalling Firm
- Aspen Surgical Products, Inc.
- Units Affected
- 124
- Distribution
- US nationwide distribution. No foreign distribution.
- Location
- Caledonia, MI
Frequently Asked Questions
What product was recalled? ▼
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400. Recalled by Aspen Surgical Products, Inc.. Units affected: 124.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2390-2021.
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