Z-1742-2017 Class II Terminated
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
- 104688
Product Description
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 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