Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 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
This recall has been terminated (originally issued March 27, 2017).
- Company
- Covidien Llc
- Recall Initiated
- March 3, 2017
- Posted
- March 27, 2017
- Terminated
- October 7, 2019
- Recall Number
- Z-1740-2017
- Quantity
- 24765540
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Product sterility is compromised due to breach of sterile barrier
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.
Lot / Code Info
Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021
Root Cause
Packaging process control
Action Taken
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.