Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility
UPDATED 11/25/2014. New lots added as follow-up to the previous Class I recall of 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. See the updated Recalled Lots listing.
UPDATED 09/05/2014. Recall Classified as Class I.
AUDIENCE: Risk Manager, Surgery, Nursing
ISSUE: 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. Affected products were manufactured from January 9, 2009 to May 19, 2014, and distributed January 2009 to May 2014.
See the firm Press Release for a listing of recalled product catalog and lot numbers.
BACKGROUND: 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).
RECOMMENDATION: Customers who have products should stop using the product lots included in the recall. Customed, Inc. is notifying its distributors by mail and arranging for the products return. Customed is requiring distributors to notify any customers who received the product through redistribution. 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form 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