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Customed, Inc recalls OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound
Recalled September 9, 2015 · FDA recall Z-2572-2015 · Customed
Hazard
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. · FDA Class II
Units
106 trays
Sold at
Distributed Only in Puerto Rico.
Description
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product
OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and 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 →