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Recall Observatory FDA recall evidence

Device 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

Z-1741-2017

March 03, 2017

Class II

Product summary

Firm
Covidien LLC
Event
Event 76606
Status
Terminated
Classification
Class II
Quantity
1659500
Official record key
device-enforcement:Z-1741-2017

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

    reason.sterility_assurance · v1.0.0

    sterility is compromised