—#153636

Product

Covidien Curity Eye Pad Item Code: 03201 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

FDA product code: HMP — Pad, Eye
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021

Why it was recalled

Product sterility is compromised due to breach of sterile barrier

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2017-03-03
Posted by FDA: 2017-03-27
Terminated: 2019-10-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153636. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.