Customed, Inc. Issues Recall of Sterile Convenience Surgical Packs
On June 3, 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.
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 & Panama; and South America-Colombia).
Customers with questions about this recall may contact Ms. Wanda Cotto, Recall Coordinator, at 1-787-801-0100 Ext. 7540, Monday through Friday, 8:00 a.m. – 5:00 p.m., Eastern Time.
Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA's MedWatch Adverse Event Reporting
program either online, by regular mail or by fax. Complete and submit
the report Online:
www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm
or call 1-800-332-1088 to request a reporting form, then complete and return
to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178