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Customed, Inc recalls ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture r
Recalled December 10, 2014 · FDA recall Z-0366-2015 · 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
6
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
ACDF Pack, catalog #900-2917 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 →