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Customed, Inc recalls Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient care procedures such as wound
Recalled December 10, 2014 · FDA recall Z-0241-2015 · Customed
Hazard
Customed products are being recalled because of 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
12300
Sold at
US Distribution to Florida, New York and Puerto Rico..
Description
Customed products are being recalled because of 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
Wound Closure Tray II, Catalog number 900-064. 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 →