FDA-Device2021-09-08Class II
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Aspen Surgical Products, Inc.
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.
Sold states
US nationwide distribution. No foreign distribution.
Affected count
1429
Manufactured in
6945 Southbelt Dr SE, N/A, Caledonia, MI, United States
Products
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2388-2021Don't want to check this manually?
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