Class 2 Device Recall Curity XRay Detectable Laparotomy Sponges

• Date Initiated by Firm: March 03, 2016
• Date Posted: May 31, 2016
• Recall Status: Terminated on June 15, 2017
• Recall Number: Z-1852-2016
• Recall Event ID: 73427
• Product Classification: Kit, i.V. Start - Product Code LRS
• Product: Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
• Code Information: All lots beginning with 110000463762 through lot 15K235262
• Recalling Firm/ Manufacturer: Covidien LLC; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: Same; 203-492-5000
• Manufacturer Reason for Recall: Compromised sterility due to breach of barrier
• FDA Determined Cause: Packaging process control
• Action: Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878
• Quantity in Commerce: 996002
• Distribution: Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.