medical Class II Updated 2021-09-08

Aspen Surgical Products, Inc. recalls Jessie Sterile Arm Suspension Kit, Product Code 711300, (pre

Recalled Product

Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots manufactured between July 9, 2019 to July 9, 2021
View official government recall

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