Ok so these are all over the place and it’s a Class One Recall and the manufacturing is done in Puerto Rico. BD
Fajardo, PR, August 22, 2014 –(PR.com)– 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. The defect could result in loss of product sterility and lead to infection. No serious injuries or deaths have been reported as of August 21, 2014. 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.Consumers who have products should stop using the product lots included in the tables below.
Customed, Inc. is:
· Notifying its distributors by mail
· Arranging for the products return (after the included response form is completed)
· Requiring distributors to notify any customers who received the product through redistribution.Affected Products Information:
· The recall includes the product catalogs and lot numbers in the table below.
· Manufacturing Dates: January 9, 2009 to May 19, 2014
· Distribution Dates: January 2009 to May 2014
The firm voluntarily recalled the products after becoming aware of the adhesion defect through Customed Quality System and has notified the FDA of this action.