Advocacy & Practice Updates — Advocacy & Practice

FDA Alert: Customed Recalls Sterile Convenience Surgical Packs

Potential defect could result in loss of product sterility

The US Food and Drug Administration (FDA) has announced that Customed, Inc (Fajardo, Puerto Rico) has initiated a recall of sterile convenience surgical packs. 

The FDA reports that the products have been found to have a potential defect due to adhesion--a defect that could result in loss of product sterility and lead to infection. According to the FDA, no serious injuries or deaths have been reported as of August 21, 2014.

The recalled products were manufactured from January 9, 2009 to May 19, 2014, and distributed from January 2009 to May 2014. The FDA reports that these products were distributed in the domestic market (Puerto Rico Commonwealth, Florida, New York State, and the US Virgin Islands), as well as the international market (Central America: Costa Rica and Panama; and South America: Colombia). 

See Customed's news release for a listing of the recalled product catalog and lot numbers.

If you have any of the products, the FDA recommends that you stop using the product lots included in the recall. Customed is notifying its distributors by mail and arranging for the products' return. 

The FDA reports that Customed also is requiring its distributors to notify any customers who received the product through redistribution. 

If you have questions about the recall, Customed advises you to contact Wanda Cotto, recall coordinator, at 1-787-801-0100, ext. 7540, Monday through Friday between 8:00 AM and 5:00 PM Eastern Time.

To report an adverse event or side effect:

  • Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178. 

Updated: August 26, 2014

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