FDAJuly 23, 2021device
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
aspen surgical productsaspenaspen surgical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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