FDAFDA · Food and drugs·Recall number Z-2390-2021
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Published September 8, 2021 · Recall initiated: July 23, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aspen Surgical Products, Inc.
- Distributor
- US nationwide distribution. No foreign distribution.
- Lot
- All lots manufactured between July 9, 2019 to July 9, 2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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