Recall Z-1739-2017— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2017-03-03, terminated 2019-10-07. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Product sterility is compromised due to breach of sterile barrier.
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-03
- Terminated
- 2019-10-07
- Firm location
- North Haven, CT, United States
Product description
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
Reason for recall
Product sterility is compromised due to breach of sterile barrier
Data sourced from openFDA. This site is unofficial and independent of the FDA.