Z-1741-2017 Class II Terminated
FDA device recall Z-1741-2017 was initiated by Covidien LLC on March 3, 2017 and is designated Class II. Reason for recall: Product sterility is compromised due to breach of sterile barrier The recall status is terminated (terminated October 7, 2019). Affected quantity: 1659500.
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2017
- Initiation Date
- March 3, 2017
- Termination Date
- October 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1659500
Product Description
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
Reason for Recall
Product sterility is compromised due to breach of sterile barrier
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.
Code Information
Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021