On October 8th, 2014 Customed, Inc. initiated a recall of sterile convenience surgical kits-trays, bags (known as "Convenience Kits"), and New Lots Added as follow-up to 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.
Potential adhesion defect which may lead to infection.
On June 3rd, 2014 Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion.