Customed, Inc., of Puerto Rico recalled 233 sterile surgical convenience 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 products were manufactured from November 1, 2011, to October 7, 2014. The affected products were distributed from November 2011 to October 9, 2014. Products were distributed within the domestic (Puerto Rico Commonwealth, Florida State, New York State, US Virgin Islands); and international market (Geographical Area Central America-Costa Rica).
See the Recall
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?