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Aspen Surgical Products, Inc. recalls Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Recalled September 8, 2021 · FDA recall Z-2388-2021 · Aspen Surgical Products
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. · FDA Class II
Units
1429
Sold at
US nationwide distribution. No foreign distribution.
Description
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.
Product
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Manufacturer(s)
Aspen Surgical Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →