Z-1743-2017 Class II Terminated
FDA device recall Z-1743-2017 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: 38794.
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
- 38794
Product Description
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
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: 14, 15, 16 Expiration Date: From February 2017 through November 2019