Press Release

Covidien Notification of Stolen Product - Single Lot of Non-Sterile Endo GIA ArticulatingTM 60 3.5mm Single Use Loading Unit

April 29, 2013 – Covidien is issuing this notification to inform the public of stolen, non-sterile Endo GIA ArticulatingTM 60-3.5 surgical stapler reloads, containing reference Code 030458 and lot number N3B0165LX. Covidien is working closely with the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations (OCI), and other law enforcement organizations, to recover the stolen, non-sterile product.

All units with the above-referenced lot number were stolen prior to sterilization. Therefore, although the product is labeled as “Sterile”; it is actually non-sterile. The Endo GIA Articulating™ surgical stapler with reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of an anastomosis. The use of non-sterile products may result in a potentially increased risk for infection and require medical intervention.

Covidien urges healthcare professionals to purchase products only from trusted and reliable sources, such as Covidien or its authorized distributors. Covidien has not distributed any units from this lot number. Users of surgical staplers should not use any units in their inventory containing lot number N3B0165LX.

The affected Product Description, Reference Code and Lot Number are listed below. All units containing this lot number are subject to this notification as Covidien has not distributed any units of this lot number.

Product Description   Reference Code Lot Number
Endo GIA ArticulatingTM 60
3.5mm Single Use Loading Unit
    030458 N3B0165LX
Anyone who has information regarding this incident, or has received suspicious or unsolicited offers for the affected products after the date of the theft, is encouraged to contact the FDA OCI at 1-800-551-3989 or to visit the OCI Web Site (http://www.fda.gov/OCI).

Covidien’s primary concern is the safety of patients and we will continue to work closely with law enforcement, the FDA, and authorized distribution partners to maintain the integrity of the supply chain. If you have questions or concerns regarding the affected devices, contact Covidien at 1-800-522-0263, option 5.
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