FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Customed Recalls Sterile Convenience Surgical Packs

Aug. 27, 2014

A Puerto Rican medical supply company is voluntarily recalling certain lots of sterile convenience surgical packs after they were found to have an adhesion defect. The problem could cause the product to become unsterile, leading to infection, Customed says.

According to the recall notice posted to the FDA website on Aug. 25, no patient injuries have been reported.

Customed initiated the recall on May 27. It includes all packs that were manufactured and distributed between January 9, 2009, and May 14, 2014.

Distributors are asked to arrange for the products return and to notify customers who received the product. The packs, which were distributed in Puerto Rico, Florida, New York, the U.S. Virgin Islands, Costa Rica, Panama and Colombia, are used in a variety of surgical procedures.

View the recall notice at www.fdanews.com/ext/resources/files/08/08-26-14CustomedRecall.pdf. — Kellen Owings

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