Class 2 Device Recall Covidien Curity Eye Pad

• Date Initiated by Firm: March 03, 2017
• Date Posted: March 27, 2017
• Recall Status: Terminated on October 07, 2019
• Recall Number: Z-1741-2017
• Recall Event ID: 76606
• Product Classification: Pad, eye - Product Code HMP
• Product: Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection
• Code Information: Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021
• 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: Product sterility is compromised due to breach of sterile barrier
• FDA Determined Cause: Packaging process control
• Action: Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. 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. Contact Medtronic representative or Customer Service at (800) 882-5878 For questions regarding this recall call 203-492-5000.
• Quantity in Commerce: 1659500
• Distribution: Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, 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.