Convenience Surgical Packs Recall; May Lose Sterility Leading to Infection

Customed, Inc., recalled sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection.


Customed's convenience sterile surgical packs are used primarily in hospitals or medical offices for surgical interventions such as: Anesthesiology; Arthroscopy; Cardiovascular; Dental, Ear, Nose, and Throat (ENT); Gastroenterology and Urology; General and Plastic Surgery; General Hospital; Neurology; Obstetrical and Gynecological; Ophthalmic; and Orthopedic procedures.


The firm voluntarily recalled the products after becoming aware of the adhesion defect through Customed Quality System and notified the FDA of this action.


Products were distributed from January 2009 to May 2014 within the domestic (Puerto Rico Commonwealth, Florida State, New York State, US Virgin Islands); and international market (Geographical Area Central America-Costa Rica & Panama; and South America-Colombia).


See the Recall


See also Medical Risk Law, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe


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