Customed, Inc., recalled additional lots of sterile convenience surgical kits (known as “convenience kits”) following the June 3, 2014, Class I recall of 233 sterile convenience surgical kits. The convenience kits have a potential package integrity defect that may compromise the sterility of the product, as well as serious deficiencies in manufacture and storage of the products that may significantly affect the risk of contamination and resultant infection. Customed recalled these products after becoming aware of potential defects through its Quality System. The FDA believes that it is unlikely that any infections that have occurred would be attributed to the convenience kits and consequently adverse events might be underreported.
Customed convenience kits are used primarily in hospitals or medical offices for patient care, wound healing, removal of sutures, etc. as well as in a wide range of surgical procedures.
The recalled convenience kits were manufactured from November 1, 2011, to October 7, 2014. The kits were distributed from November 2011 to October 9, 2014, within Puerto Rico, Florida, New York, and US Virgin Islands as well as within the international market.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?