FDA Deems Customed, Inc., Convenience Pack Recall a Class I

The U.S. Food and Drug Administration (FDA) has warned health care providers against using Customed, Inc., Surgical Packs and Convenience trays due to their lack of proof of adequate testing. These packs contain items such as instruments, absorbent towels, exam gloves, suture bags, surgical table covers, and drapes. When used in surgery, these items must be germ-free and sterile, in order to protect patients from infection. A voluntary recall was initiated by Customed, Inc. and has been deemed a Class I by the FDA.

The criteria and safety features that must be completed to pass inspection are: Sterility of products; endotoxin, a toxin that is released upon destruction of bacterial cells during sterilization; and ethylene oxide that must be within safety limits. Packaging must be able to withstand stresses during transport; expiration dates must be adhered to.

In 2014, the plastic packaging of one unit stuck to adjacent units during the sterilization process, allowing possible microorganisms to enter and contaminating the contents during separation of the package. The FDA alerted Customed, Inc.in a letter sent on December 9, 2014 citing deficiencies found during inspection.

In November 2014, Customed, Inc., resumed manufacturing without informing the FDA despite the Class 1 recall issued in October of the same year. A Class I recall is deemed by the FDA when a situation involves reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Customed, Inc.’s actions potentially posed a lack of package integrity, as well as a lack product sterility. In early 2015, the FDA became aware that the required corrections had not been made and that Customed, Inc. had continued to manufacture its product, despite the serious potential adverse health risks.

The Puerto Rico Hospital Supply company was cited as one firm that was distributing the potentially unsafe product in Puerto Rico during the time of the recall.

from Parker Waichman http://www.yourlawyer.com/blog/fda-deems-customed-inc-convenience-pack-recall-a-class-i/