Largest One-Day Device Recall on Record for Surgical Packs

The largest-ever single-day medical device recall has been reported by the FDA.

Sterility Loss

On August 26, 2014, the FDA posted 233 Class I recalls, all for sterile convenience surgical packs devices manufactured by Puerto Rico-based Customed, Inc. The packs were 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.

The company initiated the recall on June 3, 2014. Several hundred thousand units are likely affected by the recall, according to the FDA.

“Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots), ” FDA explained in the post. “This could result in an injury to the patient due to product contamination or loss of sterility condition.”

Used in Surgical Interventions

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.

The recall covers packs manufactured and distributed from January 9, 2009 to May 19, 2014. Products were distributed within the domestic (Puerto Rico Commonwealth, Florida State, New York State, U.S. Virgin Islands) and international market (geographical area Central America-Costa Rica and Panama; and South America-Colombia).

Largest One-Day Recall

According to a September 2, 2014 story on the Regulatory Affairs Professional Society website, this is the largest recall event in one day on record.

The story says that according to FDA data, the agency typically recalls between 13 and 75 devices each day, though the overwhelming majority of those recalls are either Class II or Class III recalls, which reflect lesser (and non-deadly) safety risks than Class I. Since 2004, 86% of all recalls have been Class II recalls, while 7% have been Class III and 6% have been Class I.

But, continues the article, with the exception of a few outliers, such as the November 2012 recall of 146 devices (of which all but six were Class II) and the April 2014 recall of 119 devices (of which all but one were Class II), FDA has seen relatively few major device recall events, even as the overall number of device recall events has dramatically surged since June 2012.

To read the FDA details of the recall, click here.