Device 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
Z-1739-2017
Product summary
- Firm
- Covidien LLC
- Event
- Event 76606
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7168000
- Official record key
device-enforcement:Z-1739-2017
Official wording
Reason: Product sterility is compromised due to breach of sterile barrier
Code information: Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021
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.
Derived failure modes
-
Sterility assurance
sterility is compromised