Sterile Surgical Kits Voluntarily Recalled Due to Packaging Defect

Customed, Inc, has voluntarily recalled its sterile convenience surgical kits due to a packaging defect.

The convenience kits were found to have a problem with their packaging, which could potentially compromise the sterility of the product. The kits also showed serious deficiencies in the manufacturing and storage of the products, meaning contamination or infection could occur, according to the FDA.

Generally, these products from Customed were used in hospitals or medical offices for patient care, wound healing, removal of sutures, or in a range of surgical procedures.

The products were manufactured between November 1, 2011, and October 7, 2014, and their distribution dates were from November 2011 to October 9, 2014, according to the FDA.

This recall follows on the heels of a June 3, 2014, Class I recall of 233 sterile convenience surgical kits.

Customed is sending out a message to its distributors to address the issue and arranging for the products to be returned. Distributors, in turn, will then inform customers who received the product about the recall.

As of October 9, 2014, no one has yet reported serious injuries or deaths related to these products to the FDA. However, anyone who has experienced an adverse reaction to these products can report it to the FDA’s MedWatch program by downloading a form at www.fda.gov/MedWatch/getforms.htm and submitting it online, or by requesting the form by phone at 1-800-332-1088 and mailing it in or submitting it via fax to 1-800-FDA-0178.