Device product
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 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.
Z-1745-2017
Product summary
- Firm
- Covidien LLC
- Event
- Event 76606
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1222080
- Official record key
device-enforcement:Z-1745-2017
Official wording
Reason: Product sterility is compromised due to breach of sterile barrier
Code information: Lot Number beginning with: 14, 15, 16 *Exclude lots 16J098062 16J098162 16J098262 Expiration Date: From February 2017 through November 2019
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
sterility is compromised