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Customed, Inc recalls Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures such as wound heali
Recalled December 10, 2014 · FDA recall Z-0368-2015 · Customed
Hazard
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection. · FDA Class I
Units
60
Sold at
US Distribution to Florida, New York and Puerto Rico..
Description
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Product
Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer(s)
Customed, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →